ECLIPSE: Safety and Efficacy of Cryoablation for Metastatic Lung Tumors

Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT01307501
Collaborator
(none)
40
4
1
79.8
10
0.1

Study Details

Study Description

Brief Summary

ECLIPSE will evaluate the safety and efficacy of cryoablation therapy used to treat tumors less than or equal to 3.5 centimeters (cm) in participants with pulmonary metastatic disease.

Condition or Disease Intervention/Treatment Phase
  • Device: Cryoablation
N/A

Detailed Description

ECLIPSE is a treatment, Phase 1 multicenter, prospective, single-arm study with participants serving as their own control. This study is to enroll participants who will undergo cryoablation of at least 1 metastatic pulmonary tumor that is less than or equal to 3.5 cm. Participants will be followed for 5 years post their cryoablation procedure.

Cryoablation is the process of destroying tissue by the application of extremely cold temperatures. Galil Medical Cryoablation Systems are used as a surgical tool in the fields of general surgery, dermatology (skin), neurology (nerves), chest surgery (including lung), Ears-Nose-Throat (ENT), gynecology, oncology (cancer), proctology (colon/rectal), and urology (kidney).

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
All participants received the same treatment.All participants received the same treatment.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluating Cryoablation of Metastatic Lung/Pleura Tumors in Patients - Safety and Efficacy
Actual Study Start Date :
Jan 4, 2012
Actual Primary Completion Date :
Aug 30, 2018
Actual Study Completion Date :
Aug 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Other: Cryoablation

Participants will undergo a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure will be identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and will be at the discretion of the Investigators. No more than 3 tumors in 1 lung can be treated in a single session, and no more than 5 total lung tumors (across both lungs) can be treated during the study.

Device: Cryoablation
Application of extremely cold temperatures to the identified tumor(s).
Other Names:
  • Visual-ICE® Cryoablation System
  • PresIce® Cryoablation System
  • SeedNet® Cryoablation System
  • IceRod® Cryoablation Needles
  • IceRod® PLUS Cryoablation Needles
  • IceSphere™ Cryoablation Needles
  • IceSeed™ Cryoablation Needles
  • IceEDGE™ 2.4 Cryoablation Needles
  • Outcome Measures

    Primary Outcome Measures

    1. Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 60 [Baseline and Month 60]

      Local tumor control was achieved if either the greatest trans-axial diameter of a treated tumor was ≤20% greater than at the pre-procedure assessment (per-tumor assessment) or if the sum of greatest trans-axial diameters of all treated tumors for a participant was ≤20% greater than the sum for the pre-procedure assessment of those tumors (per-participant assessment). Complete Response defined as tumor disappearance (scar) or <25% of original size. If tumor/ablation zone had likely disappeared, the measurement was recorded as 0 mm; if tumor/ablation zone was present but too small to measure, the measurement was recorded as 5 mm. Partial Response defined as greater than 30% decrease in sum of the largest diameter of all targeted tumors. Stable Disease defined as less than 30% decrease in sum of the largest diameter of all targeted tumors. Local Failure defined as greater than 20% increase in the sum of the largest diameter of all targeted tumors. Worst response per participant was used.

    Secondary Outcome Measures

    1. Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48 [Baseline and Months 3, 6, 12, 24, 36, and 48]

      Local tumor control was achieved if the greatest trans-axial diameter of a treated tumor was ≤20% greater than at the pre-procedure assessment (per-tumor assessment) or if the sum of the greatest trans-axial diameters of all treated tumors for a participant was ≤20% greater than the sum for the pre-procedure assessment of those tumors (per-participant assessment). Complete Response defined as tumor disappearance (scar) or <25% of original size. If tumor/ablation zone had likely disappeared, the measurement was recorded as 0 mm; if tumor/ablation zone was present but too small to measure, the measurement was recorded as 5 mm. Partial Response defined as greater than 30% decrease in sum of the largest diameter of all targeted tumors. Stable Disease defined as less than 30% decrease in sum of the largest diameter of all targeted tumors. Local Failure defined as greater than 20% increase in the sum of the largest diameter of all targeted tumors. Worst response per participant was used.

    2. Overall Disease-Specific Participant Survival Post-Cryoablation [Up to Month 60]

      Disease-specific survival was analyzed as time in days from study cryoablation to participant death due to lung cancer. All deaths with documented lung disease progression were categorized as disease-specific deaths for this analysis. Participants who were alive were censored at the date of their last visit. Participants who died from causes other than lung cancer and did not have documented disease progression were censored at the time of death.

    3. Time in Days to Disease Recurrence or Progression Following Study Cryoablation [Baseline (0 days), Week 1 (7 days), and Months 3 (90 days), 6 (180 days), 12 (365 days), 24 (730 days), 36 (1095 days), 48 (1460 days), and 60 (1825 days)]

      Disease recurrence or progression will be determined locally by evidence of an increase in tumor size and/or contrast enhancement that met the definition of local tumor failure. Local tumor failure defined as a >20% increase from baseline in the sum of the largest diameter of all targeted tumors. Participants without disease recurrence or progression were censored at the date of their last visit or their date of death due to any cause. The percentage of participants with disease recurrence or progression after the study cryoablation procedure at the specified number of days is presented.

    4. Change From Baseline in ECOG Performance Status at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60 [Baseline, Week 1 and Months 3, 6, 12, 24, 36, 48, and 60]

      ECOG Performance Status defined as a set of criteria with corresponding scores used by the Investigator to assess how a participant's disease is progressing, assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis. ECOG Performance Status Scoring: 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (for example, light house work, office work); 2=Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3=Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=Dead.

    5. Change From Baseline in Physical Function as Assessed by the KPS Scale at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60 [Baseline, Week 1 and Months 3, 6, 12, 24, 36, 48, and 60]

      The KPS Scale is a standard way of measuring the ability of cancer patients to perform ordinary tasks. The scores range from 0 to 100. A higher score means the participant is better able to carry out daily activities. KPS may be used to determine a participant's prognosis, to measure changes in a participant's ability to function.

    6. Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60 [Baseline, Months 1, 3, 6, 12, 24, 36, 48, and 60]

      The SF-12 is a shortened version of the well-known SF-36. The SF-12 assesses eight domains (physical functioning, role limitations due to physical health problems, bodily pain, social functioning, general mental health, role limitations due to emotional problems, vitality and general health perception). Assessments were made by examining the change in the baseline scores to those reported post-operatively. The scores range from 0 to 100. A higher value indicates a better quality of life of the participant.

    7. Cryoablation Technical Success of the Study Cryoablation Procedure [Up to 60 months]

      A technically successful treatment was defined by an ablation volume encompassing the tumor with at least a 5 mm margin. Technical success was calculated on a per tumor level as well as a participant level. To be considered a technical success on a participant level, all tumors treated during the baseline procedure were required to meet the technical success criteria (that is, an ablation volume encompassing the tumor with at least a 5 mm margin).

    8. Number of Participants With an Intra- or Post-operative Adverse Event (AE), a Serious AE, or an Unanticipated Adverse Device Effect (UADE) [Baseline up to 30 days post-cryoablation]

      An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study. Serious AEs include death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent the previously listed serious outcomes. UADE was any serious adverse effect, any life-threatening problem or death caused by or associated with a device, if it was not previously identified in nature, severity, or degree of incidence in the application; or any other unanticipated serious problem associated with a device. The AEs that are presented were considered related to the cryoablation procedure. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

    9. Metastatic Disease Spread as Measured by Imaging [Months 3, 6, 12, 24, 36, 48, and 60]

      Evidence of additional metastatic disease post cryoablation procedure as measured by imaging is presented.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Participant must be at least 18 years old.

    • Participant has signed a written informed consent.

    • Participant presents with Stage 4 pulmonary metastatic disease with metastatic disease previously confirmed by prior biopsy or confirmed on imaging with known primary disease.

    • Participant has up to 3 local metastases unilaterally targeted by cryoablation. Maximum of 5 total pulmonary tumors bilaterally.

    • Targeted tumor(s) defined as intra pulmonary or pleural with a maximum size of 3.5 cm.

    • The target tumor is determined (by CT/MRI) to be in a location where cryoablation is technically achievable based on the proximity of adjacent organs and structures.

    • Eastern Cooperative Oncology Group (ECOG) score of 0-2.

    • Karnofsky Performance Scale (KPS) score ≥60.

    • Platelet count >50,000/cubed millimeters (mm^3) within 60 days prior to study treatment.

    • International normalized ratio (INR) less than 1.5 within 60 days prior to study treatment.

    • Participant has a life expectancy of >3 months.

    • Participant is clinically suitable for cryoablation procedure.

    Exclusion Criteria:
    • Participant's primary cancer is lung cancer.

    • Participant is unable to lie flat or has respiratory distress at rest.

    • Participant has uncontrolled coagulopathy or bleeding disorders.

    • Participant has had chemotherapy with neutropenia to levels as confirmed by absolute neutrophil count (ANC) of less than 1000 that produce increase risk for the cryoablation procedure.

    • Participant has a history of an allergic reaction to iodine injections or to shellfish.

    • Participant has evidence of active systemic, pulmonary, or pericardial infection.

    • Participant has a debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up.

    • Participant is currently participating in other experimental studies that could affect the primary endpoint.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ronald Regan UCLA Medical Center Los Angeles California United States 90095
    2 Karmanos Cancer Institute Detroit Michigan United States 48201
    3 Mayo Clinic Rochester Rochester Minnesota United States 55905
    4 Institut Gustave Roussy Villejuif Cedex France 94805

    Sponsors and Collaborators

    • Boston Scientific Corporation

    Investigators

    • Study Chair: Hiran Fernando, MD, Boston Medical Center

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Boston Scientific Corporation
    ClinicalTrials.gov Identifier:
    NCT01307501
    Other Study ID Numbers:
    • CUC10-LNG06
    First Posted:
    Mar 3, 2011
    Last Update Posted:
    Jul 19, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Boston Scientific Corporation

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Cryoablation
    Arm/Group Description Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.
    Period Title: Overall Study
    STARTED 40
    Intent-to-Treat (ITT) Population 40
    COMPLETED 17
    NOT COMPLETED 23

    Baseline Characteristics

    Arm/Group Title Cryoablation
    Arm/Group Description Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.
    Overall Participants 40
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    62.6
    (13.3)
    Sex: Female, Male (Count of Participants)
    Female
    16
    40%
    Male
    24
    60%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    2
    5%
    Not Hispanic or Latino
    19
    47.5%
    Unknown or Not Reported
    19
    47.5%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    1
    2.5%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    2
    5%
    White
    17
    42.5%
    More than one race
    1
    2.5%
    Unknown or Not Reported
    19
    47.5%
    Eastern Cooperative Oncology Group (ECOG) Performance Status (score on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [score on a scale]
    0.3
    (0.5)
    Physical Function as Assessed by the Karnofsky Performance Status (KPS) Scale (score on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [score on a scale]
    95.5
    (8.1)
    Quality of Life Over Time as Assessed by the Short Form-12 (SF-12) Generic Measure (score on a scale) [Mean (Standard Deviation) ]
    Physical Functioning
    71.2
    (34.9)
    Role Physical
    62.1
    (29.7)
    Bodily Pain
    77.3
    (26.8)
    Social Functioning
    80.5
    (26.7)
    Mental Health
    69.5
    (18.2)
    Role Emotional
    78.4
    (21.0)
    Vitality
    57.8
    (22.4)
    General Health Perception
    63.9
    (23.3)

    Outcome Measures

    1. Primary Outcome
    Title Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 60
    Description Local tumor control was achieved if either the greatest trans-axial diameter of a treated tumor was ≤20% greater than at the pre-procedure assessment (per-tumor assessment) or if the sum of greatest trans-axial diameters of all treated tumors for a participant was ≤20% greater than the sum for the pre-procedure assessment of those tumors (per-participant assessment). Complete Response defined as tumor disappearance (scar) or <25% of original size. If tumor/ablation zone had likely disappeared, the measurement was recorded as 0 mm; if tumor/ablation zone was present but too small to measure, the measurement was recorded as 5 mm. Partial Response defined as greater than 30% decrease in sum of the largest diameter of all targeted tumors. Stable Disease defined as less than 30% decrease in sum of the largest diameter of all targeted tumors. Local Failure defined as greater than 20% increase in the sum of the largest diameter of all targeted tumors. Worst response per participant was used.
    Time Frame Baseline and Month 60

    Outcome Measure Data

    Analysis Population Description
    Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point.
    Arm/Group Title Cryoablation
    Arm/Group Description Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.
    Measure Participants 40
    Measure Tumors 60
    Local Control, Month 60
    80.0
    Complete Response, Month 60
    45.0
    Partial Response, Month 60
    15.0
    Stable Disease, Month 60
    20.0
    Local Failure, Month 60
    20.0
    2. Secondary Outcome
    Title Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48
    Description Local tumor control was achieved if the greatest trans-axial diameter of a treated tumor was ≤20% greater than at the pre-procedure assessment (per-tumor assessment) or if the sum of the greatest trans-axial diameters of all treated tumors for a participant was ≤20% greater than the sum for the pre-procedure assessment of those tumors (per-participant assessment). Complete Response defined as tumor disappearance (scar) or <25% of original size. If tumor/ablation zone had likely disappeared, the measurement was recorded as 0 mm; if tumor/ablation zone was present but too small to measure, the measurement was recorded as 5 mm. Partial Response defined as greater than 30% decrease in sum of the largest diameter of all targeted tumors. Stable Disease defined as less than 30% decrease in sum of the largest diameter of all targeted tumors. Local Failure defined as greater than 20% increase in the sum of the largest diameter of all targeted tumors. Worst response per participant was used.
    Time Frame Baseline and Months 3, 6, 12, 24, 36, and 48

    Outcome Measure Data

    Analysis Population Description
    Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point.
    Arm/Group Title Cryoablation
    Arm/Group Description Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.
    Measure Participants 40
    Measure Tumors 60
    Local Control, Month 3
    46.4
    Local Control, Month 6
    66.7
    Local Control, Month 12
    80.4
    Local Control, Month 24
    87.5
    Local Control, Month 48
    90.9
    Local Control, Month 36
    90.3
    Complete Response, Month 3
    5.4
    Complete Response, Month 6
    15.8
    Complete Response, Month 12
    23.5
    Complete Response, Month 24
    40.0
    Complete Response, Month 36
    38.7
    Complete Response, Month 48
    40.9
    Partial Response, Month 3
    3.6
    Partial Response, Month 6
    10.5
    Partial Response, Month 12
    15.7
    Partial Response, Month 24
    10.0
    Partial Response, Month 36
    16.1
    Partial Response, Month 48
    22.7
    Stable Disease, Month 3
    37.5
    Stable Disease, Month 6
    40.4
    Stable Disease, Month 12
    41.2
    Stable Disease, Month 24
    37.5
    Stable Disease, Month 36
    35.5
    Stable Disease, Month 48
    27.3
    Local Failure, Month 3
    53.6
    Local Failure, Month 6
    33.3
    Local Failure, Month 12
    19.6
    Local Failure, Month 24
    12.5
    Local Failure, Month 36
    9.7
    Local Failure, Month 48
    9.1
    3. Secondary Outcome
    Title Overall Disease-Specific Participant Survival Post-Cryoablation
    Description Disease-specific survival was analyzed as time in days from study cryoablation to participant death due to lung cancer. All deaths with documented lung disease progression were categorized as disease-specific deaths for this analysis. Participants who were alive were censored at the date of their last visit. Participants who died from causes other than lung cancer and did not have documented disease progression were censored at the time of death.
    Time Frame Up to Month 60

    Outcome Measure Data

    Analysis Population Description
    Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point.
    Arm/Group Title Cryoablation
    Arm/Group Description Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.
    Measure Participants 40
    Week 1
    100
    250%
    Month 1
    100
    250%
    Month 3
    100
    250%
    Month 6
    100
    250%
    Month 12
    100
    250%
    Month 24
    86.5
    216.3%
    Month 36
    74.8
    187%
    Month 48
    71.5
    178.8%
    Month 60
    55.3
    138.3%
    4. Secondary Outcome
    Title Time in Days to Disease Recurrence or Progression Following Study Cryoablation
    Description Disease recurrence or progression will be determined locally by evidence of an increase in tumor size and/or contrast enhancement that met the definition of local tumor failure. Local tumor failure defined as a >20% increase from baseline in the sum of the largest diameter of all targeted tumors. Participants without disease recurrence or progression were censored at the date of their last visit or their date of death due to any cause. The percentage of participants with disease recurrence or progression after the study cryoablation procedure at the specified number of days is presented.
    Time Frame Baseline (0 days), Week 1 (7 days), and Months 3 (90 days), 6 (180 days), 12 (365 days), 24 (730 days), 36 (1095 days), 48 (1460 days), and 60 (1825 days)

    Outcome Measure Data

    Analysis Population Description
    Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point.
    Arm/Group Title Cryoablation
    Arm/Group Description Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.
    Measure Participants 40
    Baseline
    0
    0%
    Week 1 (7 days)
    0
    0%
    Month 1 (30 days)
    0
    0%
    Month 3 (90 days)
    0
    0%
    Month 6 (180 days)
    2.5
    6.3%
    Month 12 (365 days)
    5.1
    12.8%
    Month 24 (730 days)
    10.7
    26.8%
    Month 36 (1095 days)
    10.7
    26.8%
    Month 48 (1460 days)
    10.7
    26.8%
    Month 60 (1825 days)
    21.8
    54.5%
    5. Secondary Outcome
    Title Change From Baseline in ECOG Performance Status at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60
    Description ECOG Performance Status defined as a set of criteria with corresponding scores used by the Investigator to assess how a participant's disease is progressing, assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis. ECOG Performance Status Scoring: 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (for example, light house work, office work); 2=Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3=Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=Dead.
    Time Frame Baseline, Week 1 and Months 3, 6, 12, 24, 36, 48, and 60

    Outcome Measure Data

    Analysis Population Description
    Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point.
    Arm/Group Title Cryoablation
    Arm/Group Description Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.
    Measure Participants 40
    Change at Week 1
    0.1
    (0.5)
    Change at Month 1
    0
    (0.4)
    Change at Month 3
    0.2
    (0.4)
    Change at Month 6
    0.1
    (0.4)
    Change at Month 12
    0.2
    (0.6)
    Change at Month 24
    0.2
    (0.6)
    Change at Month 36
    -0.1
    (0.5)
    Change at Month 48
    0.2
    (0.8)
    Change at Month 60
    0.6
    (1.0)
    6. Secondary Outcome
    Title Change From Baseline in Physical Function as Assessed by the KPS Scale at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60
    Description The KPS Scale is a standard way of measuring the ability of cancer patients to perform ordinary tasks. The scores range from 0 to 100. A higher score means the participant is better able to carry out daily activities. KPS may be used to determine a participant's prognosis, to measure changes in a participant's ability to function.
    Time Frame Baseline, Week 1 and Months 3, 6, 12, 24, 36, 48, and 60

    Outcome Measure Data

    Analysis Population Description
    Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point.
    Arm/Group Title Cryoablation
    Arm/Group Description Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.
    Measure Participants 40
    Baseline
    95.5
    (8.1)
    Change at Week 1
    -1.8
    (6.1)
    Change at Month 1
    -0.9
    (5.3)
    Change at Month 3
    -1.6
    (6.3)
    Change at Month 6
    0.3
    (7.2)
    Change at Month 12
    -0.5
    (8.4)
    Change at Month 24
    4.4
    (7.3)
    Change at Month 36
    7.8
    (4.4)
    Change at Month 48
    5.0
    (5.5)
    Change at Month 60
    6.7
    (5.8)
    7. Secondary Outcome
    Title Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
    Description The SF-12 is a shortened version of the well-known SF-36. The SF-12 assesses eight domains (physical functioning, role limitations due to physical health problems, bodily pain, social functioning, general mental health, role limitations due to emotional problems, vitality and general health perception). Assessments were made by examining the change in the baseline scores to those reported post-operatively. The scores range from 0 to 100. A higher value indicates a better quality of life of the participant.
    Time Frame Baseline, Months 1, 3, 6, 12, 24, 36, 48, and 60

    Outcome Measure Data

    Analysis Population Description
    Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point.
    Arm/Group Title Cryoablation
    Arm/Group Description Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.
    Measure Participants 40
    Physical Functioning, Change at Month 1
    -10.0
    (24.2)
    Physical Functioning, Change at Month 3
    -12.0
    (24.4)
    Physical Functioning, Change at Month 6
    -12.5
    (33.0)
    Physical Functioning, Change at Month 12
    -23.9
    (38.0)
    Physical Functioning, Change at Month 24
    -10.4
    (44.5)
    Physical Functioning, Change at Month 36
    -12.5
    (31.7)
    Physical Functioning, Change at Month 48
    -10.7
    (31.8)
    Physical Functioning, Change at Month 60
    -12.5
    (54.2)
    Role Physical, Change at Month 1
    4.2
    (24.2)
    Role Physical, Change at Month 3
    -1.9
    (21.0)
    Role Physical, Change at Month 6
    -0.4
    (19.7)
    Role Physical, Change at Month 12
    -2.2
    (26.8)
    Role Physical, Change at Month 24
    5.2
    (23.5)
    Role Physical, Change at Month 36
    5.0
    (25.8)
    Role Physical, Change at Month 48
    3.6
    (35.9)
    Role Physical, Change at Month 60
    -4.2
    (25.8)
    Bodily Pain, Change at Month 1
    -9.2
    (25.8)
    Bodily Pain, Change at Month 3
    -3.7
    (21.6)
    Bodily Pain, Change at Month 6
    -9.8
    (24.9)
    Bodily Pain, Change at Month 12
    -7.6
    (19.1)
    Bodily Pain, Change at Month 24
    -18.8
    (32.2)
    Bodily Pain, Change at Month 36
    -5.0
    (30.7)
    Bodily Pain, Change at Month 48
    0
    (28.9)
    Bodily Pain, Change at Month 60
    -8.3
    (49.2)
    Social Functioning, Change at Month 1
    -8.6
    (26.1)
    Social Functioning, Change at Month 3
    -3.7
    (23.7)
    Social Functioning, Change at Month 6
    -4.6
    (22.0)
    Social Functioning, Change at Month 12
    -11.4
    (24.1)
    Social Functioning, Change at Month 24
    -12.5
    (32.9)
    Social Functioning, Change at Month 36
    -2.5
    (24.9)
    Social Functioning, Change at Month 48
    -3.6
    (39.3)
    Social Functioning, Change at Month 60
    -12.5
    (37.9)
    Mental Health, Change at Month 1
    1.7
    (16.3)
    Mental Health, Change at Month 3
    0.9
    (12.0)
    Mental Health, Change at Month 6
    -1.4
    (10.6)
    Mental Health, Change at Month 12
    -0.6
    (20.6)
    Mental Health, Change at Month 24
    -3.1
    (17.0)
    Mental Health, Change at Month 36
    3.8
    (15.6)
    Mental Health, Change at Month 48
    8.9
    (9.4)
    Mental Health, Change at Month 60
    0
    (13.7)
    Role Emotional, Change at Month 1
    -3.3
    (20.5)
    Role Emotional, Change at Month 3
    -11.6
    (23.0)
    Role Emotional, Change at Month 6
    -2.7
    (24.4)
    Role Emotional, Change at Month 12
    -3.8
    (21.1)
    Role Emotional, Change at Month 24
    -11.5
    (24.1)
    Role Emotional, Change at Month 36
    -11.3
    (27.9)
    Role Emotional, Change at Month 48
    -8.9
    (15.7)
    Role Emotional, Change at Month 60
    -22.9
    (26.7)
    Vitality, Change at Month 1
    -6.0
    (22.8)
    Vitality, Change at Month 3
    -9.3
    (19.8)
    Vitality, Change at Month 6
    -6.5
    (22.6)
    Vitality, Change at Month 12
    -10.2
    (24.0)
    Vitality, Change at Month 24
    -14.6
    (22.5)
    Vitality, Change at Month 36
    -2.5
    (27.5)
    Vitality, Change at Month 48
    -7.1
    (23.8)
    Vitality, Change at Month 60
    -4.2
    (29.2)
    General Health Perception, Change at Month 1
    -3.8
    (19.9)
    General Health Perception, Change at Month 3
    2.4
    (26.1)
    General Health Perception, Change at Month 6
    0
    (23.5)
    General Health Perception, Change at Month 12
    -5.2
    (31.4)
    General Health Perception, Change at Month 24
    -11.3
    (22.2)
    General Health Perception, Change at Month 36
    -14.5
    (24.1)
    General Health Perception, Change at Month 48
    -14.3
    (28.9)
    General Health Perception, Change at Month 60
    -22.5
    (33.6)
    8. Secondary Outcome
    Title Cryoablation Technical Success of the Study Cryoablation Procedure
    Description A technically successful treatment was defined by an ablation volume encompassing the tumor with at least a 5 mm margin. Technical success was calculated on a per tumor level as well as a participant level. To be considered a technical success on a participant level, all tumors treated during the baseline procedure were required to meet the technical success criteria (that is, an ablation volume encompassing the tumor with at least a 5 mm margin).
    Time Frame Up to 60 months

    Outcome Measure Data

    Analysis Population Description
    Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
    Arm/Group Title Cryoablation
    Arm/Group Description Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.
    Measure Participants 40
    Measure Tumors 60
    Number [percentage of tumors]
    100
    9. Secondary Outcome
    Title Number of Participants With an Intra- or Post-operative Adverse Event (AE), a Serious AE, or an Unanticipated Adverse Device Effect (UADE)
    Description An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study. Serious AEs include death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent the previously listed serious outcomes. UADE was any serious adverse effect, any life-threatening problem or death caused by or associated with a device, if it was not previously identified in nature, severity, or degree of incidence in the application; or any other unanticipated serious problem associated with a device. The AEs that are presented were considered related to the cryoablation procedure. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
    Time Frame Baseline up to 30 days post-cryoablation

    Outcome Measure Data

    Analysis Population Description
    Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
    Arm/Group Title Cryoablation
    Arm/Group Description Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.
    Measure Participants 40
    Intra-operative nonserious AE (NSAE)
    23
    57.5%
    Post-operative NSAE, prior to discharge
    9
    22.5%
    Post-operative NSAE within 30 days of procedure
    19
    47.5%
    Serious AE
    6
    15%
    UADE
    0
    0%
    10. Secondary Outcome
    Title Metastatic Disease Spread as Measured by Imaging
    Description Evidence of additional metastatic disease post cryoablation procedure as measured by imaging is presented.
    Time Frame Months 3, 6, 12, 24, 36, 48, and 60

    Outcome Measure Data

    Analysis Population Description
    Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point.
    Arm/Group Title Cryoablation
    Arm/Group Description Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.
    Measure Participants 40
    Month 3
    16
    40%
    Month 6
    14
    35%
    Month 12
    14
    35%
    Month 24
    10
    25%
    Month 36
    9
    22.5%
    Month 48
    7
    17.5%
    Month 60
    6
    15%

    Adverse Events

    Time Frame Baseline up to Month 60
    Adverse Event Reporting Description Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
    Arm/Group Title Cryoablation
    Arm/Group Description Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.
    All Cause Mortality
    Cryoablation
    Affected / at Risk (%) # Events
    Total 20/40 (50%)
    Serious Adverse Events
    Cryoablation
    Affected / at Risk (%) # Events
    Total 6/40 (15%)
    Infections and infestations
    Appendicitis 1/40 (2.5%)
    Injury, poisoning and procedural complications
    Vascular access complication 1/40 (2.5%)
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax 3/40 (7.5%)
    Vascular disorders
    Bilateral subdural hematoma 1/40 (2.5%)
    Other (Not Including Serious) Adverse Events
    Cryoablation
    Affected / at Risk (%) # Events
    Total 32/40 (80%)
    Gastrointestinal disorders
    Nausea 1/40 (2.5%)
    Vomiting 1/40 (2.5%)
    General disorders
    Fever 1/40 (2.5%)
    Flu like symptoms 1/40 (2.5%)
    Non-cardiac chest pain 1/40 (2.5%)
    Pain 1/40 (2.5%)
    Pain at procedure site 2/40 (5%)
    Infections and infestations
    Lung infection 1/40 (2.5%)
    Skin infection 1/40 (2.5%)
    Injury, poisoning and procedural complications
    Burn 1/40 (2.5%)
    Intraoperative hemorrhage 2/40 (5%)
    Postoperative hemorrhage 1/40 (2.5%)
    Musculoskeletal and connective tissue disorders
    Back Pain 2/40 (5%)
    Chest wall pain 1/40 (2.5%)
    Pain in left arm 1/40 (2.5%)
    Nervous system disorders
    Headache 1/40 (2.5%)
    Reproductive system and breast disorders
    Vaginal inflammation 1/16 (6.3%)
    Respiratory, thoracic and mediastinal disorders
    Alveolar hemorrhage 1/40 (2.5%)
    Atelectasis 2/40 (5%)
    Cough 3/40 (7.5%)
    Hemoptysis 1/40 (2.5%)
    Pleural effusion 11/40 (27.5%)
    Pleural hemorrhage 2/40 (5%)
    Pneumothorax 19/40 (47.5%)
    Shortness of breath 2/40 (5%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    BTG can require Investigator to postpone publications/presentations for up to 12 months so data from all sites can be published. BTG will limit review of Investigator's draft to confirm Confidential Information is not being disclosed. If BTG notes publishing Study results may affect obtaining a patent, Investigator will not publish for up to 60 days until patent application is filed. Investigator will acknowledge BTG in any publication/presentation.

    Results Point of Contact

    Name/Title Sr. Clinical Trial Specialist
    Organization Galil Medical, a wholly owned indirect subsidiary of Boston Scientific
    Phone 651-287-5000
    Email GalilClinical@bsci.com
    Responsible Party:
    Boston Scientific Corporation
    ClinicalTrials.gov Identifier:
    NCT01307501
    Other Study ID Numbers:
    • CUC10-LNG06
    First Posted:
    Mar 3, 2011
    Last Update Posted:
    Jul 19, 2021
    Last Verified:
    Jul 1, 2021