Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Leiomyoma

Myofibroma

Myoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

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.

The Halt 2000 Electrosurgical Radiofrequency Ablation System is indicated for use in percutaneous, laparoscopic and intraoperative, coagulation and ablation of soft tissue.

Halt Procedure

Mary Hinckley, MD

Micah Harris, MD

Erika Banks, MD

Karen R Abbott, MD

Jay Berman, MD

Jose G Garza Leal, MD

David Levine, MD

Rodolfo Robles Pemueller, MD

Jennifer Israel, MD

Richard S Guido, MD

James Macer, MD

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.

Laparoscopic Radiofrequency Ablation (RFA) of Symptomatic Uterine Fibroids

Evaluation of the Halt System for Laparoscopic Treatment of Symptomatic Uterine Fibroids With Radiofrequency Ablation

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.

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).

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.

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.

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.

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.

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

Acessa Health, Inc.

The Safety Set consisted of all subjects treated in the study.

Safety Set

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.

Halt Medical Acessa Procedure

Age, Categorical

Age US Sites (n=86)

Age Latin America (n=51)

Age, Continuous

Sex: Female, Male

United States

Mexico

Guatemala

Region of Enrollment

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.

Laura Kemp, Sr. VP Clinical Affairs

50% change in MBF

40% change in MBF

30% change in MBF

22% change in MBF

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.

Change of Menstrual Blood Flow(MBF) @ 12 Months Post Treatment

Assessment of Menstrual Blood Flow (MBF) at 12 Months Post Procedure

Device-related events are those that the investigator considered to be definitely, probably, or possibly related to the device.

Device Related Adverse Events

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.

Procedural

Incidence of Device and Procedure-related Adverse Events Within 12 Months Post-procedure

The Per Protocol Set was the primary analysis set for surgical reintervention.

Surgical Reintervention 12 Months Post Treatment

Surgical Re-Intervention for Menorrhagia at 12 Months Post-treatment

Uterine volume assessment 12 months post treatment via contrast enhanced MRI

Change in Uterine Volume

Fibroid volume assessment 12 months post treatment via contrast enhanced MRI

Change in Fibroid Volume

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.

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)

All treated subjects who met all inclusion and exclusion criteria and who completed the Symptom Severity Questionnaire at Baseline and 12 months.

Full Analysis Set - Symptom Severity

All treated subjects who met all inclusion and exclusion Criteria and who completed the HRQL questionnaire at both baseline and 12 months.

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.

All subjects who completed the Health State Score Questionnaire (EQ-5D) at both baseline and at 12 months post treatment.

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)

Somewhat Satisfied/Effective

Moderately Satisfied/Effective

Very Satisfied/Effective

Patients were asked, overall, how satisfied with their uterine fibroid treatment.

Overall, Satisfaction With Uterine Fibroid Treatment

Patients were asked to respond in their opinion, how effective was this treatment in eliminating their symptoms.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Laparoscopic Radiofrequency Ablation (RFA) of Symptomatic Uterine Fibroids	NCT00874029	Uterine Fibroid... Uterine Myomas	Halt Procedure	25 Years -	Acessa Health, Inc.
Laparoscopic Radiofrequency Ablation (RFA) of Symptomatic Uterine Fibroids	NCT00874029	Uterine Fibroid... Uterine Myomas	Halt Procedure	25 Years -	Acessa Health, Inc.

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