NEUWAVE Flex Microwave Ablation System in the Ablation of Primary Soft Tissue Lesions of the Lung

• Sponsor: Ethicon, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03603652
• Collaborator: (none)
• Enrollment: 10
• Locations: 5
• Arm: 1
• Actual Duration (Months): 15.8
• Patients Per Site: 2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Patients with medically inoperable primary soft tissue lesion of the lung will have transbronchial microwave ablation performed via transbronchial approach by an interventional pulmonologist or thoracic surgeon using CT imaging. Prior to the ablation procedure, the treating physician will use endobronchial ultrasound to confirm staging. Patients will be followed for one year following the ablation procedure for efficacy and safety.

Condition or Disease	Intervention/Treatment	Phase
Cancer of Lung; Cancer of the Lung; Lung Cancer; Neoplasms, Lung; Carcinoma, Non-Small Cell Lung; Non-Small Cell Lung Cancer; Non-Small-Cell Lung Carcinoma	Device: Microwave Ablation	N/A

Detailed Description

Patients with medically inoperable primary soft tissue lesion of the lung (lesions less than or equal to 2cm and located in the outer two-thirds of the lung and not closer than 1cm to the pleura) will have transbronchial microwave ablation performed using CT imaging. All ablations will be performed under general anesthesia via transbronchial approach by an interventional pulmonologist or thoracic surgeon.

Prior to the ablation procedure, the treating physician will use endobronchial ultrasound to confirm staging.

Patients will be followed for one year following the ablation procedure for efficacy and safety with specific follow-up visits at 30 days, 6 months, and 12 months post-ablation. A user experience questionnaire is completed by the treating physician to better understand the ease of the procedure.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter Study of the NEUWAVE Flex Microwave Ablation System in the Ablation of Medically Inoperable Primary Soft Tissue Lesions of the Lung: An Initial Experience
• Actual Study Start Date: Jun 29, 2018
• Actual Primary Completion Date: Dec 21, 2018
• Actual Study Completion Date: Oct 24, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Microwave Ablation Ablations will be performed under general anesthesia via transbronchial approach by an interventional pulmonologist or thoracic surgeon.	Device: Microwave Ablation; Ablations will be performed under general anesthesia via transbronchial approach by an interventional pulmonologist or thoracic surgeon. Prior to the ablation, the treating physician will perform an endobronchial ultrasound to confirm disease staging.

Outcome Measures

Primary Outcome Measures

1. Number of Patients Whose Ablation Resulted in Technical Success [Immediately post-ablation (day 0)]

   Ablation of the target lesion according to the protocol and covered completely, with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an ablative margin), as assessed by CBCT imaging, immediately following the procedure.

2. Number of Patients Whose Ablation Resulted in Technique Efficacy [30 days post-ablation]

   Ablation of the target lesion according to the protocol and covered completely, with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an ablative margin), as assessed by CT imaging, 30 days (+/- 7 days) after the first ablation procedure.

3. User Experience Survey (Part I) [Immediately post-ablation]

   A Sponsor-created survey completed by the treating physician immediately post-ablation. Questions were all YES/NO.

4. User Experience Survey (Part II) [Immediately post-ablation]

   A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked the time it took to place the probe in a position that was ready for ablation.

5. User Experience Survey (Part III) [Immediately post-ablation]

   A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked how many cone-beam CT (CBCT) scans were taken to place the probe such that it was ready for ablation.

6. User Experience Survey (Part IV) [Immediately post-ablation]

   A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked the distance of the tip of the probe to the center of the soft-tissue lesion (in mm) just before the ablation procedure was initiated.

7. User Experience Survey (Part V) [Immediately post-ablation]

   A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked how many times the probe had to be repositioned to complete the ablation procedure.

Secondary Outcome Measures

1. Number of Patients Who Experienced Target Lesion Recurrence [measured at 6 months and 1 year post-ablation]

   Analyzed at 6 months and 1 year post-ablation via CT imaging

2. Number of Patients Who Were Readmitted to the Hospital [Within 30 days post-ablation]

   Any readmission to the hospital within 30 days of the ablation procedure.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Signed informed consent.

2. Patients ≥ 18 years old.

3. Performance status 0-2 via ECOG (Eastern Cooperative Oncology Group) classification.

4. Willing to fulfill all follow-up visit requirements.

5. Medically inoperable primary soft tissue lesion of the lung or patient election not to have surgery. (Medically inoperable is defined per the following indicators: post op predictive FEV1 (forced expiratory volume in 1 second) < 40%; DLCO (diffusing capacity of the lung for carbon monoxide) < 40%; hypoxemia or hypercapnia diabetes with end-organ damage; or severe cerebral, cardiovascular, peripheral vascular disease, or chronic heart disease)

6. One soft tissue lesion ≤ 2 cm in the outer two thirds of the lung and not closer than 1 cm to the pleura.

(Outer two thirds of the lung is defined as peripheral beyond the segmental airway, past the segmental bronchi, such that proximal endobronchial soft tissue lesions are avoided; soft tissue lesions should not be contiguous with the pleura)

1. Radiographic resolution of pneumonia

Exclusion Criteria:

1. Scheduled concurrent procedure for the target soft tissue lesion other than those that are lung related.

2. Pregnant or breastfeeding.

3. Physical or psychological condition that would impair study participation.

4. Patients with uncorrectable coagulography at time of screening.

5. Patient with implantable devices, including pacemakers or other electronic implants.

6. Prior pneumonectomy or bronchiectasis.

7. Severe neuromuscular disease.

8. Platelet count ≤ 50,000/mm3.

9. ASA (American Society of Anesthesiologists) score of ≥ 4.

10. Inability to tolerate anesthesia.

11. Expected survival less than 6 months.

12. Clinically significant hypertension.

13. Chronic ventilator support, which uses bi-level positive airway pressure (PAP).

14. Endobronchial soft tissue lesions proximal to the segmental airways

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope	Duarte	California	United States	91010
2	Mayo Clinic	Rochester	Minnesota	United States	55905
3	New York Presbyterian-Weill Cornell Medicine	New York	New York	United States	10065
4	FirstHealth Moore Regional Hospital	Pinehurst	North Carolina	United States	28374
5	Cleveland Clinic	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• Ethicon, Inc.

Investigators

• Principal Investigator: Thomas Gildea, MD, The Cleveland Clinic
• Principal Investigator: Michael Pritchett, MD, FirstHealth Moore Regional Hospital
• Principal Investigator: Janani Reisenauer, MD, Mayo Clinic
• Principal Investigator: Bradley Pua, MD, Cornell
• Principal Investigator: Jae Kim, MD, City of Hope Medical Center

Study Documents (Full-Text)

• Statistical Analysis Plan - Jan 29, 2020
• Study Protocol - Jul 25, 2018

More Information

Publications

None provided.

• Responsible Party: Ethicon, Inc.
• ClinicalTrials.gov Identifier: NCT03603652
• Other Study ID Numbers: NEU_2017_06
• First Posted: Jul 27, 2018
• Last Update Posted: Dec 21, 2020
• Last Verified: Dec 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Ethicon, Inc.: Lung Lesions; Soft Tissue- Lung
• Additional relevant MeSH terms: Carcinoma; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Study Results

Participant Flow

Arm/Group Title	Microwave Ablation
Arm/Group Description	Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
Period Title: Overall Study
STARTED	10
COMPLETED	8
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Microwave Ablation
Arm/Group Description	Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
Overall Participants	10
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	69.3 (7.689)
Sex: Female, Male (Count of Participants)
Female	6 60%
Male	4 40%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	10 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 10%
White	9 90%
More than one race	0 0%
Unknown or Not Reported	0 0%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	26.8 (4.469)
Smoking Status (Count of Participants)
Current Smoker	3 30%
Former Smoker	6 60%
Non-Smoker	1 10%
Radiation History (Count of Participants)
Yes, radiation history	1 10%
No, radiation history	9 90%

Outcome Measures

1. Primary Outcome

Title	Number of Patients Whose Ablation Resulted in Technical Success
Description	Ablation of the target lesion according to the protocol and covered completely, with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an ablative margin), as assessed by CBCT imaging, immediately following the procedure.
Time Frame	Immediately post-ablation (day 0)

Outcome Measure Data

Analysis Population Description

All treated patients.

Arm/Group Title	Microwave Ablation
Arm/Group Description	Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
Measure Participants	10
10	10 100%

2. Primary Outcome

Title	Number of Patients Whose Ablation Resulted in Technique Efficacy
Description	Ablation of the target lesion according to the protocol and covered completely, with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an ablative margin), as assessed by CT imaging, 30 days (+/- 7 days) after the first ablation procedure.
Time Frame	30 days post-ablation

Outcome Measure Data

Analysis Population Description

Patients analyzed at 30 days post-ablation.

Arm/Group Title	Microwave Ablation
Arm/Group Description	Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
Measure Participants	9
Count of Participants [Participants]	9 90%

3. Secondary Outcome

Title	Number of Patients Who Experienced Target Lesion Recurrence
Description	Analyzed at 6 months and 1 year post-ablation via CT imaging
Time Frame	measured at 6 months and 1 year post-ablation

Outcome Measure Data

Analysis Population Description

Only 9 patients were analyzed at 6 months post-ablation as 1 patient passed away before the 6 month study visit.

Arm/Group Title	Microwave Ablation
Arm/Group Description	Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
Measure Participants	9
Count of Participants [Participants]	0 0%

4. Secondary Outcome

Title	Number of Patients Who Were Readmitted to the Hospital
Description	Any readmission to the hospital within 30 days of the ablation procedure.
Time Frame	Within 30 days post-ablation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Microwave Ablation
Arm/Group Description	Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
Measure Participants	10
Count of Participants [Participants]	1 10%

5. Primary Outcome

Title	User Experience Survey (Part I)
Description	A Sponsor-created survey completed by the treating physician immediately post-ablation. Questions were all YES/NO.
Time Frame	Immediately post-ablation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Microwave Ablation
Arm/Group Description	Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
Measure Participants	10
YES	10 100%
YES	6 60%
YES	10 100%
YES	10 100%
YES	10 100%
YES	10 100%
YES	7 70%

6. Primary Outcome

Title	User Experience Survey (Part II)
Description	A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked the time it took to place the probe in a position that was ready for ablation.
Time Frame	Immediately post-ablation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Microwave Ablation
Arm/Group Description	Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
Measure Participants	10
Mean (Standard Deviation) [Minutes]	18.2 (11.25)

7. Primary Outcome

Title	User Experience Survey (Part III)
Description	A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked how many cone-beam CT (CBCT) scans were taken to place the probe such that it was ready for ablation.
Time Frame	Immediately post-ablation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Microwave Ablation
Arm/Group Description	Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
Measure Participants	10
Mean (Standard Deviation) [Count of Scans]	4.4 (3.44)

8. Primary Outcome

Title	User Experience Survey (Part IV)
Description	A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked the distance of the tip of the probe to the center of the soft-tissue lesion (in mm) just before the ablation procedure was initiated.
Time Frame	Immediately post-ablation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Microwave Ablation
Arm/Group Description	Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
Measure Participants	10
Mean (Standard Deviation) [Millimeters]	4.1 (2.23)

9. Primary Outcome

Title	User Experience Survey (Part V)
Description	A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked how many times the probe had to be repositioned to complete the ablation procedure.
Time Frame	Immediately post-ablation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Microwave Ablation
Arm/Group Description	Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
Measure Participants	10
Mean (Standard Deviation) [Count of Probe Repositions]	0.9 (0.93)

Adverse Events

Time Frame	1 year following the initial ablation procedure.
Adverse Event Reporting Description	Participants were evaluated for AEs and SAEs at every study visit starting with the ablation procedure through the end-of-study (1 year following the initial ablation procedure).
Arm/Group Title	Microwave Ablation
Arm/Group Description	Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
All Cause Mortality
	Microwave Ablation
	Affected / at Risk (%)	# Events
Total	2/10 (20%)
Serious Adverse Events
	Microwave Ablation
	Affected / at Risk (%)	# Events
Total	3/10 (30%)
Infections and infestations
Infected Bite	1/10 (10%)	1
Nervous system disorders
Ataxia	1/10 (10%)	1
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease	1/10 (10%)	5
Vascular disorders
Haemorrhage	1/10 (10%)	1
Other (Not Including Serious) Adverse Events
	Microwave Ablation
	Affected / at Risk (%)	# Events
Total	9/10 (90%)
Gastrointestinal disorders
Nausea	3/10 (30%)	4
General disorders
Fatigue	3/10 (30%)	3
Pyrexia	2/10 (20%)	2
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain	3/10 (30%)	3
Musculoskeletal Pain	2/10 (20%)	2
Respiratory, thoracic and mediastinal disorders
Hemoptysis	6/10 (60%)	6
Cough	4/10 (40%)	4
Chronic Obstructive Pulmonary Disease	2/10 (20%)	9
Dyspnea	2/10 (20%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.