Laparoscopic Radiofrequency Ablation (RFA) of Symptomatic Uterine Fibroids

Acessa Health, Inc.137 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

137

Conditions

Uterine Fibroids Uterine Myomas

Interventions

Halt ProcedureDEVICE

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

Eligibility

Sex: FEMALEMin age: 25 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (11)

Women's Health Research

Phoenix, Arizona, United States

USC Medical Center

Los Angeles, California, United States

Pasadena Premier Women's Health

Pasadena, California, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)

Data from ClinicalTrials.gov

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