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

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ClinicalTrials.gov Identifier: NCT00874029
Recruitment Status : Completed
First Posted : April 2, 2009
Results First Posted : July 3, 2014
Last Update Posted : July 3, 2014
Sponsor:
Information provided by (Responsible Party):
Acessa Health, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Uterine Fibroids
Uterine Myomas
Intervention Device: Halt Procedure
Enrollment 137
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 Details 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
Hide 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
Reason Not Completed
Withdrawal by Subject             10
Pregnancy             4
Physician Decision             1
Adverse Event             1
Lost to Follow-up             5
Arm/Group Title Halt Medical Acessa Procedure
Hide 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 Number of Baseline Participants 137
Hide Baseline Analysis Population Description
Subjects who met the initial inclusion exclusion criteria were enrolled and treated. Two subjects were later found to have baseline bleeding volumes outside of the protocol inclusion limits. All 137 Subjects comprised the Safety Set. The Full Analysis Set excluded the two subjects that did not meet the baseline bleeding criteria.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 137 participants
<=18 years
0
   0.0%
Between 18 and 65 years
137
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 137 participants
Age US Sites (n=86)
43.4
(34 to 55)
Age Latin America (n=51)
40.7
(31 to 50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 137 participants
Female
137
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 137 participants
United States 86
Mexico 28
Guatemala 23
1.Primary Outcome
Title Assessment of Menstrual Blood Flow (MBF) at 12 Months Post Procedure
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Change of Menstrual Blood Flow(MBF) @ 12 Months Post Treatment
Hide 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.
Overall Number of Participants Analyzed 124
Measure Type: Number
Unit of Measure: Percentage of participants
50% change in MBF 40.2
40% change in MBF 48.8
30% change in MBF 59.1
22% change in MBF 67.7
2.Primary Outcome
Title Incidence of Device and Procedure-related Adverse Events Within 12 Months Post-procedure
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Device Related Adverse Events Procedural
Hide 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.
Overall Number of Participants Analyzed 137 137
Measure Type: Number
Unit of Measure: participants
5 33
3.Primary Outcome
Title Surgical Re-Intervention for Menorrhagia at 12 Months Post-treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Surgical Reintervention 12 Months Post Treatment
Hide Arm/Group Description:
The Per Protocol Set was the primary analysis set for surgical reintervention.
Overall Number of Participants Analyzed 124
Measure Type: Number
Unit of Measure: participants
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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 128 119
Mean (95% Confidence Interval)
Unit of Measure: percentage of volume
-25
(-30.41 to -19.52)
-44.3
(-50.84 to -37.84)
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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Full Analysis Set - Symptom Severity Full Analysis Set - Health Related Quality of Life (HRQL)
Hide 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.
Overall Number of Participants Analyzed 129 129
Mean (Standard Deviation)
Unit of Measure: 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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Full Analysis Set - Month 12 Health Status Change
Hide Arm/Group Description:
All subjects who completed the Health State Score Questionnaire (EQ-5D) at both baseline and at 12 months post treatment.
Overall Number of Participants Analyzed 128
Mean (Standard Deviation)
Unit of Measure: Units on a scale
15.2  (20.219)
7.Secondary Outcome
Title Overall Subject Treatment Outcome and Satisfaction Using the Overall Treatment Evaluation (OTE)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall, Satisfaction With Uterine Fibroid Treatment How Effective Was This Treatment in Eliminating Symptoms
Hide 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.
Overall Number of Participants Analyzed 124 124
Measure Type: Number
Unit of Measure: percentage of patients
Somewhat Satisfied/Effective 12.1 14.5
Moderately Satisfied/Effective 21.0 29.8
Very Satisfied/Effective 61.3 50.0
Time Frame Baseline thru 36 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Safety Set
Hide Arm/Group Description The Safety Set consisted of all subjects treated in the study.
All-Cause Mortality
Safety Set
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Safety Set
Affected / at Risk (%) # Events
Total   15/137 (10.95%)    
Endocrine disorders   
Anemia, resulting in blood transfusion   1/137 (0.73%)  2
Infections and infestations   
Viral Infection with Otitis Media   1/137 (0.73%)  1
Musculoskeletal and connective tissue disorders   
Achilles tendon rupture and intervertebral disc repair   1/137 (0.73%)  1
Hemiparesis   1/137 (0.73%)  1
Mild Stroke   1/137 (0.73%)  1
Renal and urinary disorders   
Pyelonephritis   1/137 (0.73%)  1
Reproductive system and breast disorders   
Uterine Hemorrhage   1/137 (0.73%)  1
Spontaneous Abortion   1/137 (0.73%)  1
Pelvic Abscess   1/137 (0.73%)  1
Pulmonary Embolus   1/137 (0.73%)  1
Respiratory, thoracic and mediastinal disorders   
Atelactasis   1/137 (0.73%)  1
Chest Pain   2/137 (1.46%)  2
Dyspnea   1/137 (0.73%)  1
MVA   1/137 (0.73%)  1
Surgical and medical procedures   
Laceration in serosa of colon   1/137 (0.73%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Safety Set
Affected / at Risk (%) # Events
Total   7/137 (5.11%)    
Infections and infestations   
Urinary Tract Infection   7/137 (5.11%)  7
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Laura Kemp, Sr. VP Clinical Affairs
Organization: Halt Medical, Inc
Phone: 408-375-1465
EMail: lkemp@haltmedical.com
Layout table for additonal information
Responsible Party: Acessa Health, Inc.
ClinicalTrials.gov Identifier: NCT00874029     History of Changes
Other Study ID Numbers: CP-00-0004
First Submitted: April 1, 2009
First Posted: April 2, 2009
Results First Submitted: October 24, 2013
Results First Posted: July 3, 2014
Last Update Posted: July 3, 2014