An interventional study of Halt Procedure in Uterine Fibroids and Uterine Myomas, sponsored by Acessa Health, Inc.. Completed at 11 sites in 3 countries. Open to female participants aged 25 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-03.
Sponsored by Acessa Health, Inc. · Not applicable, Interventional, and Treatment
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.
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.
490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.
This study's enrollment of 137 is above the median of 62 across 345 interventional studies indexed under Leiomyoma.
Browse Leiomyoma studies →Acessa Health, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Also known as: Halt, Halt2000, The Halt System, The Halt 2000 System
Assessment of Menstrual Blood Flow (MBF) at 12 Months Post Procedure
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
Incidence of Device and Procedure-related Adverse Events Within 12 Months Post-procedure
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
Surgical Re-Intervention for Menorrhagia at 12 Months Post-treatment
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
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)
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
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.
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
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)
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
Overall Subject Treatment Outcome and Satisfaction Using the Overall Treatment Evaluation (OTE)
The Overall Treatment Evaluation Survey refers to whether the patient felt symptoms improved, worsened or remained the same post treatment.
Time frame: 12 months
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.
| Milestone | Halt Procedure |
|---|---|
| Started | 137 |
| Completed | 116 |
| Not completed | 21 |
| Withdrew: Withdrawal by subject | 10 |
| Withdrew: Pregnancy | 4 |
| Withdrew: Physician decision | 1 |
| Withdrew: Adverse event | 1 |
| Withdrew: Lost to follow-up | 5 |
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.
| Percentage of participants | Change of Menstrual Blood Flow(MBF) @ 12 Months Post Treatment |
|---|---|
| 50% change in MBF | 40.2 (31.6 to 48.7) |
| 40% change in MBF | 48.8 (40.1 to 57.5) |
| 30% change in MBF | 59.1 (50.5 to 67.6) |
| 22% change in MBF | 67.7 (59.6 to 75.8) |
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).
| participants | Device Related Adverse Events | Procedural |
|---|---|---|
| Incidence of Device and Procedure-related Adverse Events Within 12 Months Post-procedure | 5 | 33 |
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.
| participants | Surgical Reintervention 12 Months Post Treatment |
|---|---|
| Surgical Re-Intervention for Menorrhagia at 12 Months Post-treatment | 0 |
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.
| percentage of volume | Change in Uterine Volume | Change in Fibroid Volume |
|---|---|---|
| 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) | -25 ± 135.7 | -44.3 ± 47.98 |
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.
| Units on a scale | Full Analysis Set - Symptom Severity | Full Analysis Set - Health Related Quality of Life (HRQL) |
|---|---|---|
| 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. | -34.93 ± 23.339 | 42.12 ± 23.060 |
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.
| Units on a scale | Full Analysis Set - Month 12 Health Status Change |
|---|---|
| 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) | 15.2 ± 20.219 |
The Overall Treatment Evaluation Survey refers to whether the patient felt symptoms improved, worsened or remained the same post treatment.
| percentage of patients | Overall, Satisfaction With Uterine Fibroid Treatment | How Effective Was This Treatment in Eliminating Symptoms |
|---|---|---|
| Somewhat Satisfied/Effective | 12.1 | 14.5 |
| Moderately Satisfied/Effective | 21.0 | 29.8 |
| Very Satisfied/Effective | 61.3 | 50.0 |
Collected over Baseline thru 36 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Safety Set | — | 15/137 (10.9%) | 7/137 (5.1%) |
| Event | Safety Set |
|---|---|
| Chest PainRespiratory, thoracic and mediastinal disorders | 2/137 |
| AtelactasisRespiratory, thoracic and mediastinal disorders | 1/137 |
| Viral Infection with Otitis MediaInfections and infestations | 1/137 |
| PyelonephritisRenal and urinary disorders | 1/137 |
| Uterine HemorrhageReproductive system and breast disorders | 1/137 |
| Achilles tendon rupture and intervertebral disc repairMusculoskeletal and connective tissue disorders | 1/137 |
| Laceration in serosa of colonSurgical and medical procedures | 1/137 |
| Spontaneous AbortionReproductive system and breast disorders | 1/137 |
| Pelvic AbscessReproductive system and breast disorders | 1/137 |
| HemiparesisMusculoskeletal and connective tissue disorders | 1/137 |
| Event | Safety Set |
|---|---|
| Urinary Tract InfectionInfections and infestations | 7/137 |
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(Participants) | Halt Medical Acessa Procedure |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 137 |
| >=65 years | 0 |
| Age, Continuous(years) | Halt Medical Acessa Procedure |
|---|---|
| Age US Sites (n=86) | 43.4 ± 4.0 |
| Age Latin America (n=51) | 40.7 ± 4.9 |
| Sex: Female, Male(Participants) | Halt Medical Acessa Procedure |
|---|---|
| Female | 137 |
| Male | 0 |
| Region of Enrollment(participants) | Halt Medical Acessa Procedure |
|---|---|
| United States | 86 |
| Mexico | 28 |
| Guatemala | 23 |
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Acessa Health, Inc.