Halt: Laparoscopic Radiofrequency Ablation (RFA) of Symptomatic Uterine Fibroids

• Sponsor: Acessa Health, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00874029
• Collaborator: (none)
• Enrollment: 137
• Locations: 11
• Arm: 1
• Duration (Months): 60
• Patients Per Site: 12.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to demonstrate the safety and effectiveness of radiofrequency ablation (RFA) using the Halt System for the treatment of patients with symptomatic uterine fibroids.

Condition or Disease	Intervention/Treatment	Phase
Uterine Fibroids; Uterine Myomas	Device: Halt Procedure	N/A

Detailed Description

In this single-arm study, subjects who have symptomatic uterine fibroids will have laparoscopic surgery in which intra-abdominal ultrasound will guide RF ablation of uterine fibroids using the Halt System.

Study Design

• Study Type: Interventional
• Actual Enrollment: 137 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Halt System for Laparoscopic Treatment of Symptomatic Uterine Fibroids With Radiofrequency Ablation
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Halt Procedure In this single-arm study, subjects who have symptomatic uterine fibroids will have the Halt Procedure in which intra-abdominal ultrasound will guide RF ablation of uterine fibroids using the Halt System.	Device: Halt Procedure; The Halt 2000 Electrosurgical Radiofrequency Ablation System is indicated for use in percutaneous, laparoscopic and intraoperative, coagulation and ablation of soft tissue.; Other Names: Halt Halt2000 The Halt System The Halt 2000 System

Outcome Measures

Primary Outcome Measures

1. Assessment of Menstrual Blood Flow (MBF) at 12 Months Post Procedure [12 months from Baseline]

   Change in volume of menstrual blood loss at 12 months post-procedure compared to baseline. Bleeding relief and surgical reintervention were the co-primary endpoints. Bleeding relief success was defined for individual subjects as a ≥ 50% reduction from baseline in menstrual blood loss at 12 months posttreatment. The Primary Full Analysis Set was the primary analysis set for bleeding success rate.

2. Incidence of Device and Procedure-related Adverse Events Within 12 Months Post-procedure [12 months]

   An adverse event was defined as any untoward medical occurrence in a subject who uses a medical device, regardless of the presumed relationship of the event to the study device. A serious adverse event is defined as an untoward medical occurrence that results in death, is life threatening, requires or prolongs hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect. Preexisting conditions (i.e., underlying diseases that were present before the adverse event reporting period began), re-intervention for failure to meet the study endpoints, and pregnancy were not reported as adverse events. All adverse events that occured during the study were recorded on the Adverse Event case report form (CRF). The investigator recorded the adverse event and assessed the relationship of the adverse event to the device and/or procedure; the coding of the events was reviewed by the Clinical Events Committee (CEC).

3. Surgical Re-Intervention for Menorrhagia at 12 Months Post-treatment [12 months from Baseline]

   Patients who had surgical reintervention for bleeding prior to 12 months follow-up. Surgical reintervention success was defined as no surgical reintervention for menorrhagia within the 12-month posttreatment period.

Secondary Outcome Measures

1. Change in Uterine and Fibroid Volume at 12 Months Post-procedure Compared to Pre-procedure (Baseline) as Measured With Contrast-enhanced MRI (Magnetic Resonance Imaging) [12 month from Baseline]

   Evaluate change from baseline in uterine volume and fibroid volume at 12 months post-procedure as measured by contrast-enhanced magnetic resonance imaging (MRI) measurements. Specifically, the outcomes of uterine and fibroid volume changes are expressed as a mean percentage of volume reduction. Treatment with RFA resulted in a reduction from baseline in total uterine and fibroid volume, as assessed by pretreatment and posttreatment MRI, at 3 and 12 months posttreatment.

2. Change in Fibroid Symptom Severity and Quality of Life Scores at 12 Months Post-procedure as Compared to Pre-procedure (Baseline) Using the Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QoL) Assessment Tool. [12 months from Baseline]

   The Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QoL) assessment tool measures symptom severity and Health related quality of life. Symptom Severity (SS) - high scores indicate greater symptoms (bad) and low scores indicate less symptoms (good). Scores range from 0 to 100. Since this outcome measure indicates "change" in symptoms, a negative number indicates a reduction in symptoms and therefore improvement. Health Related (HRQL) - high scores indicate better health state. Scores range from 0 to 100. Since this outcome measure indicates "change" in health and quality of life, a positive number indicates and improvement.

3. Change in Score on Questionnaire - General Health Outcome at 12 Months Post-procedure as Compared to Pre-procedure Using the EQ-5D (a Standardized Instrument for Use as a Measure of Health Outcome) [12 months]

   The EQ-5D is a standardized instrument with scores ranging from 0 to 100, for use as a measure of general health outcome, such as mobility, self-care, usual activities, pain/discomfort and anxiety and depression. An increase in the score post treatment indicates less disease burden.

4. Overall Subject Treatment Outcome and Satisfaction Using the Overall Treatment Evaluation (OTE) [12 months]

   The Overall Treatment Evaluation Survey refers to whether the patient felt symptoms improved, worsened or remained the same post treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Are premenopausal and ≥ 25 years old

• Have symptomatic uterine fibroids

• Have a uterine gestational size ≤14 weeks as determined by pelvic exam

• Have ≤ 6 (six) treatable fibroids in whom no single fibroid exceeds 7 cm in any diameter as measured by ultrasound or magnetic resonance imaging (MRI). Only Fibroids greater than 1cm in diameter should be treated in this study

• Have a total uterine fibroid volume that does not exceed 300cc on ultrasound or contrast-enhanced MRI evaluation

• Have clinical menorrhagia as indicated by menstrual blood loss of ≥160 mL to 500 ml during one baseline cycle or two baseline cycles within three months prior to treatment

• Have a history of at least 3 months of menorrhagia within the last six months

• Desire uterine preservation

• Do not desire current or future childbearing

• Have a normal coagulation profile international normalized ratio (INR), Platelets, Prothrombin Time, and Partial Thromboplastin Time (PTT)

• Have had a normal Pap smear within the past 12 months

• Are practicing non-hormonal or stable hormonal contraception

• If the woman is not currently taking any hormonal contraceptives, has been off all hormonal contraceptives for a minimum of three months prior to study enrollment, and agrees to continue without change in regimen through the 12 months of follow-up OR

• If the woman is currently taking hormonal contraceptives, has taken hormonal contraceptives for a minimum of three months prior to study enrollment, and agrees to continue without change in regimen through 12 months of follow up.**

**Note: Hormonal contraceptive use must be terminated 30 days prior to treatment but should be resumed post-operatively within 60 days post treatment as instructed by the Investigator.

• Are willing and able to comply with all study tests, procedures, and assessment tools

• Are willing and able to return for all required follow up visits following study enrollment

• Must pass a pre-operative health exam (ASA I-III)

• Are capable of providing informed consent

Exclusion Criteria:

• Have contraindications for laparoscopic surgery and/or general anesthesia. (Contraindications include anemia, defined as a hemoglobin level under 10 or hematocrit level less than 30.)

• Have had prior pelvic surgery (with the exception of C-section, tubal ligation, or diagnostic laparoscopy), or are known to have significant intra-abdominal adhesions (defined as adhesions that would require extensive dissection to mobilize and view all surfaces of the uterus)

• Have previously undergone endometrial ablation, uterine artery embolization, or uterine artery ligation, or any other uterine-preserving technique for reduction of menstrual bleeding (with the exception of hysteroscopic myomectomy > 1 year ago)

• Patients requiring elective concomitant procedures

• Have contraindications for magnetic resonance imaging (MRI)

• Desire current or future childbearing

• Are pregnant or lactating

• Have taken any Gonadotropin-releasing hormone (GnRh) agonist within three months prior to the screening procedures

• Have an implanted intrauterine or fallopian tube device for contraception that cannot or will not be removed one month prior to treatment

• Have dysfunctional uterine bleeding or bleeding between periods

• Have chronic pelvic pain not due to uterine fibroids

• Have known or suspected endometriosis

• Have known or suspected adenomyosis based on Ultrasound or MRI findings

• Have active or history of pelvic inflammatory disease

• Have a history of or evidence of gynecologic malignancy or pre-malignancy within the past five years

• Have had pelvic radiation

• Have a non-uterine pelvic mass

• Have a cervical myoma

• Have one or more pedunculated subserosal fibroids or "type zero" (completely intracavitary) submucous fibroids

• Are peri-menopausal (defined as women 40 years of age or older with Follicular Stimulating Hormone level of ≥ 25 International Units (IU) or menopausal

• Are unable to give informed consent

• In the medical judgment of the investigator should not participate in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Women's Health Research	Phoenix	Arizona	United States	85015
2	USC Medical Center	Los Angeles	California	United States	90033
3	Pasadena Premier Women's Health	Pasadena	California	United States	91145
4	Reproductive Science Center	San Ramon	California	United States	94583
5	Wayne State University	Detroit	Michigan	United States	48034
6	St. Luke's Hospital	Chesterfield	Missouri	United States	63017
7	Athena Gynecology Medical Group	Reno	Nevada	United States	89509
8	Montefiore Medical Center	Bronx	New York	United States	10461
9	Magee-Women's Hospital	Pittsburgh	Pennsylvania	United States	15213
10	Hospital Universitario Esperanza	Guatemala City		Guatemala	01010
11	Hospital Universitario Dr. Jose Eleuterio Gonzalez de la Universidad Autonoma de Nuevo Leon. Facultad de Medicina	Monterrey	Nuevo Leon	Mexico	64460

Sponsors and Collaborators

• Acessa Health, Inc.

Investigators

• Principal Investigator: Mary Hinckley, MD, Reproductive Science Center
• Principal Investigator: Micah Harris, MD, Women's Health Research
• Principal Investigator: Erika Banks, MD, Montefiore Medical Center
• Principal Investigator: Karen R Abbott, MD, Athena Gynecology Medical Group
• Principal Investigator: Jay Berman, MD, Wayne State University
• Principal Investigator: Jose G Garza Leal, MD, Hospital Universitario Dr. Jose Eleuterio Gonzalez
• Principal Investigator: David Levine, MD, St. Johns' Mercy Medical Center
• Principal Investigator: Rodolfo Robles Pemueller, MD, Universidad Francisco Marroquín
• Principal Investigator: Jennifer Israel, MD, University of Southern California
• Principal Investigator: Richard S Guido, MD, Magee-Women's Hospital
• Principal Investigator: James Macer, MD, Pasadena Premier Women's Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Acessa Health, Inc.
• ClinicalTrials.gov Identifier: NCT00874029
• Other Study ID Numbers: CP-00-0004
• First Posted: Apr 2, 2009
• Last Update Posted: Jul 3, 2014
• Last Verified: Jun 1, 2014

• Keywords provided by Acessa Health, Inc.: Uterine Fibroids; Myomas
• Additional relevant MeSH terms: Leiomyoma; Myofibroma

Study Results

Participant Flow

Recruitment Details	Recruitment began in February 2009 with enrollment of the last patient in February 2011. All subjects were enrolled at nine clinical sites throughout the United States and two clinical sites in Latin America.
Pre-assignment Detail	Subjects were excluded for the following: radiologic evidence by MRI of adenomyosis (n = 127), pedunculated subserosal or intracavitary myomas (n = 43), a history of pelvic malignancy, cervical dysplasia, a prior procedure to treat or remove myomas (n = 22), and contraindications to anesthesia or abdominal surgery (n = 12).

Arm/Group Title	Halt Procedure
Arm/Group Description	In this single-arm study, subjects who have symptomatic uterine fibroids will have the Halt Procedure in which intra-abdominal ultrasound will guide RF ablation of uterine fibroids using the Halt System.
Period Title: Overall Study
STARTED	137
COMPLETED	116
NOT COMPLETED	21

Baseline Characteristics

Arm/Group Title	Halt Medical Acessa Procedure
Arm/Group Description	In this single-arm study, subjects who have symptomatic uterine fibroids had the Acessa Procedure using the Halt Medical Proprietary Acessa System. The Acessa System delivers monopolar radiofrequency energy to tissue through a disposable electrosurgical radiofrequency (RF) Handpiece. The Generator provides sinusoidally-varying voltage at 460 kilohertz (kHz) to drive a current through the tissue to be ablated. The current delivered through the Handpiece causes controlled, local heating, resulting in targeted tissue destruction. The heat produced then disperses by conduction. During these controlled ablations, the Generator produces an alternating current which flows between the Handpiece and the dispersive electrode pads, through the body of the patient. These components, coupled with the visualization capabilities of laparoscopic ultrasound, enable the surgeon to accurately identify the patient's uterine fibroids and treat all of her fibroids, and just the fibroids.
Overall Participants	137
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	137 100%
>=65 years	0 0%
Age (years) [Median (Full Range) ]
Age US Sites (n=86)	43.4 (4.0)
Age Latin America (n=51)	40.7 (4.9)
Sex: Female, Male (Count of Participants)
Female	137 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	86 62.8%
Mexico	28 20.4%
Guatemala	23 16.8%

Outcome Measures

1. Primary Outcome

Title	Assessment of Menstrual Blood Flow (MBF) at 12 Months Post Procedure
Description	Change in volume of menstrual blood loss at 12 months post-procedure compared to baseline. Bleeding relief and surgical reintervention were the co-primary endpoints. Bleeding relief success was defined for individual subjects as a ≥ 50% reduction from baseline in menstrual blood loss at 12 months posttreatment. The Primary Full Analysis Set was the primary analysis set for bleeding success rate.
Time Frame	12 months from Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Change of Menstrual Blood Flow(MBF) @ 12 Months Post Treatment
Arm/Group Description	Of the 137 subjects enrolled and treated under this protocol, 124 (90.5%) were considered "evaluable" in terms of their 1) ability to provide a menstrual blood loss assessment, 2) lack of concomitant disease that affects the menstrual cycle, 3) baseline menstrual blood loss was within protocol inclusion limits.
Measure Participants	124
50% change in MBF	40.2 29.3%
40% change in MBF	48.8 35.6%
30% change in MBF	59.1 43.1%
22% change in MBF	67.7 49.4%

2. Primary Outcome

Title	Incidence of Device and Procedure-related Adverse Events Within 12 Months Post-procedure
Description	An adverse event was defined as any untoward medical occurrence in a subject who uses a medical device, regardless of the presumed relationship of the event to the study device. A serious adverse event is defined as an untoward medical occurrence that results in death, is life threatening, requires or prolongs hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect. Preexisting conditions (i.e., underlying diseases that were present before the adverse event reporting period began), re-intervention for failure to meet the study endpoints, and pregnancy were not reported as adverse events. All adverse events that occured during the study were recorded on the Adverse Event case report form (CRF). The investigator recorded the adverse event and assessed the relationship of the adverse event to the device and/or procedure; the coding of the events was reviewed by the Clinical Events Committee (CEC).
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device Related Adverse Events	Procedural
Arm/Group Description	Device-related events are those that the investigator considered to be definitely, probably, or possibly related to the device.	Procedure-related events are those that the investigator considered to be definitely, probably, or possibly related to the procedure, including those related to abdominal entry and anesthesia.
Measure Participants	137	137
Number [participants]	5 3.6%	33 NaN

3. Primary Outcome

Title	Surgical Re-Intervention for Menorrhagia at 12 Months Post-treatment
Description	Patients who had surgical reintervention for bleeding prior to 12 months follow-up. Surgical reintervention success was defined as no surgical reintervention for menorrhagia within the 12-month posttreatment period.
Time Frame	12 months from Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Surgical Reintervention 12 Months Post Treatment
Arm/Group Description	The Per Protocol Set was the primary analysis set for surgical reintervention.
Measure Participants	124
Number [participants]	0 0%

4. Secondary Outcome

Title	Change in Uterine and Fibroid Volume at 12 Months Post-procedure Compared to Pre-procedure (Baseline) as Measured With Contrast-enhanced MRI (Magnetic Resonance Imaging)
Description	Evaluate change from baseline in uterine volume and fibroid volume at 12 months post-procedure as measured by contrast-enhanced magnetic resonance imaging (MRI) measurements. Specifically, the outcomes of uterine and fibroid volume changes are expressed as a mean percentage of volume reduction. Treatment with RFA resulted in a reduction from baseline in total uterine and fibroid volume, as assessed by pretreatment and posttreatment MRI, at 3 and 12 months posttreatment.
Time Frame	12 month from Baseline

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) was used in the analysis of the change in total uterine and fibroid volumes between baseline and 12 months post treatment. Of the 137 Subjects enrolled, two were excluded from the FAS because they did not meet all of the inclusion/exclusion criteria.

Arm/Group Title	Change in Uterine Volume	Change in Fibroid Volume
Arm/Group Description	Uterine volume assessment 12 months post treatment via contrast enhanced MRI	Fibroid volume assessment 12 months post treatment via contrast enhanced MRI
Measure Participants	128	119
Mean (95% Confidence Interval) [percentage of volume]	-25 (135.7)	-44.3 (47.98)

5. Secondary Outcome

Title	Change in Fibroid Symptom Severity and Quality of Life Scores at 12 Months Post-procedure as Compared to Pre-procedure (Baseline) Using the Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QoL) Assessment Tool.
Description	The Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QoL) assessment tool measures symptom severity and Health related quality of life. Symptom Severity (SS) - high scores indicate greater symptoms (bad) and low scores indicate less symptoms (good). Scores range from 0 to 100. Since this outcome measure indicates "change" in symptoms, a negative number indicates a reduction in symptoms and therefore improvement. Health Related (HRQL) - high scores indicate better health state. Scores range from 0 to 100. Since this outcome measure indicates "change" in health and quality of life, a positive number indicates and improvement.
Time Frame	12 months from Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Full Analysis Set - Symptom Severity	Full Analysis Set - Health Related Quality of Life (HRQL)
Arm/Group Description	All treated subjects who met all inclusion and exclusion criteria and who completed the Symptom Severity Questionnaire at Baseline and 12 months.	All treated subjects who met all inclusion and exclusion Criteria and who completed the HRQL questionnaire at both baseline and 12 months.
Measure Participants	129	129
Mean (Standard Deviation) [Units on a scale]	-34.93 (23.339)	42.12 (23.060)

6. Secondary Outcome

Title	Change in Score on Questionnaire - General Health Outcome at 12 Months Post-procedure as Compared to Pre-procedure Using the EQ-5D (a Standardized Instrument for Use as a Measure of Health Outcome)
Description	The EQ-5D is a standardized instrument with scores ranging from 0 to 100, for use as a measure of general health outcome, such as mobility, self-care, usual activities, pain/discomfort and anxiety and depression. An increase in the score post treatment indicates less disease burden.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Full Analysis Set - Month 12 Health Status Change
Arm/Group Description	All subjects who completed the Health State Score Questionnaire (EQ-5D) at both baseline and at 12 months post treatment.
Measure Participants	128
Mean (Standard Deviation) [Units on a scale]	15.2 (20.219)

7. Secondary Outcome

Title	Overall Subject Treatment Outcome and Satisfaction Using the Overall Treatment Evaluation (OTE)
Description	The Overall Treatment Evaluation Survey refers to whether the patient felt symptoms improved, worsened or remained the same post treatment.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overall, Satisfaction With Uterine Fibroid Treatment	How Effective Was This Treatment in Eliminating Symptoms
Arm/Group Description	Patients were asked, overall, how satisfied with their uterine fibroid treatment.	Patients were asked to respond in their opinion, how effective was this treatment in eliminating their symptoms.
Measure Participants	124	124
Somewhat Satisfied/Effective	12.1	14.5
Moderately Satisfied/Effective	21.0	29.8
Very Satisfied/Effective	61.3	50.0

Adverse Events

Time Frame	Baseline thru 36 months
Arm/Group Title	Safety Set
Arm/Group Description	The Safety Set consisted of all subjects treated in the study.
All Cause Mortality
	Safety Set
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Safety Set
	Affected / at Risk (%)	# Events
Total	15/137 (10.9%)
Endocrine disorders
Anemia, resulting in blood transfusion	1/137 (0.7%)	2
Infections and infestations
Viral Infection with Otitis Media	1/137 (0.7%)	1
Musculoskeletal and connective tissue disorders
Achilles tendon rupture and intervertebral disc repair	1/137 (0.7%)	1
Hemiparesis	1/137 (0.7%)	1
Mild Stroke	1/137 (0.7%)	1
Renal and urinary disorders
Pyelonephritis	1/137 (0.7%)	1
Reproductive system and breast disorders
Uterine Hemorrhage	1/137 (0.7%)	1
Spontaneous Abortion	1/137 (0.7%)	1
Pelvic Abscess	1/137 (0.7%)	1
Pulmonary Embolus	1/137 (0.7%)	1
Respiratory, thoracic and mediastinal disorders
Atelactasis	1/137 (0.7%)	1
Chest Pain	2/137 (1.5%)	2
Dyspnea	1/137 (0.7%)	1
MVA	1/137 (0.7%)	1
Surgical and medical procedures
Laceration in serosa of colon	1/137 (0.7%)	1
Other (Not Including Serious) Adverse Events
	Safety Set
	Affected / at Risk (%)	# Events
Total	7/137 (5.1%)
Infections and infestations
Urinary Tract Infection	7/137 (5.1%)	7

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.