Post Market TRUST - U.S.A. Study

Not Applicable

Active, not recruiting

• Conditions: Symptomatic Uterine Fibroids
• Interventions: Procedure: Global Fibroid Ablation (GFA); Procedure: Abdominal or Laparoscopic Myomectomy; Procedure: Uterine Artery Embolization (UAE)

• Registration Number: NCT02163525
• Lead Sponsor: Acessa Health, Inc.

Brief Summary

This Post Market study is being conducted to compare the direct and indirect cost of three approaches (GFA, myomectomy, and uterine artery embolization) for the treatment of symptomatic uterine fibroids. In addition, data from this study is being used to satisfy the requirements of the United States Food and Drug Administration's 522 (post market surveillance) order.

Detailed Description

The purpose of this study is to 1) evaluate the economic burden, safety and outcomes of three uterine-conserving treatment alternatives for symptomatic uterine fibroids: myomectomy, uterine artery embolization (UAE), and global fibroid ablation (GFA) using the Acessa™ System, and 2) meet the requirements of the U.S. Food and Drug Administration's 522 Order for post market surveillance In this study, subjects who have symptomatic uterine fibroids will be randomized to one of three uterine-conserving treatments based on the local standard of care.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-11
• Study First Submitted QC: 2014-06-11
• Study First Posted: 2014-06-13
• Primary Completion: 2019-07
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-11
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 114

Inclusion Criteria

• Are ≥ 18 years old and menstruating
• Have symptomatic uterine fibroids
• Have a uterine size ≤ 16 gestational weeks as determined by pelvic exam
• Have all fibroids that are less than 10 cm in any diameter
• Desire uterine conservation
• Have had a normal Pap smear within the past 36 months defined as "no untreated cervical malignancy or dysplasia."
• Are willing and able to comply with all study tests, procedures, and assessment tools
• Are capable of providing informed consent.

Exclusion Criteria

• Have contraindications for laparoscopic surgery and/or general anesthesia.
• Are expected to be high risk for, 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)
• Patients requiring major elective concomitant procedures (e.g., hernia repair)
• Are pregnant or lactating
• Have taken any depot 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 at least 10 days prior to treatment
• Have chronic pelvic pain known to not be due to uterine fibroids
• Have known or suspected endometriosis Stage 3 or 4, adenomyosis
• 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 over 3 cm
• Have a cervical myoma
• Have one or more completely intracavitary submucous fibroids (Type 0) or only Type 0/1 submucous fibroids that are better treated via hysteroscopic methods
• In the medical judgment of the investigator should not participate in the study
• Are not willing to be randomized to treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ablation vs Myomectomy	Abdominal or Laparoscopic Myomectomy	Women are randomized 1:1 to either global fibroid ablation (GFA) or myomectomy (laparoscopic or abdominal)
Ablation vs Embolization	Global Fibroid Ablation (GFA)	Women are randomized 1:1 to either global fibroid ablation (GFA) or uterine artery embolization (UAE)
Ablation vs Embolization	Uterine Artery Embolization (UAE)	Women are randomized 1:1 to either global fibroid ablation (GFA) or uterine artery embolization (UAE)
Ablation vs Myomectomy	Global Fibroid Ablation (GFA)	Women are randomized 1:1 to either global fibroid ablation (GFA) or myomectomy (laparoscopic or abdominal)

Primary Outcome Measures

Name	Time	Method
Compare direct cost of GFA compared to those of myomectomy and UAE	3 months post procedure	To compare medical, surgical, and hospitalization costs (including procedural complication costs) of Global Fibroid Ablation (GFA) compared to those of Myomectomy and Uterine Artery Embolization (UAE)at 3 months post procedure.
Compare rates of acute and near-term serious complications to the acute and near-term treatment-related serious adverse events of pivotal study.	30 days post procedure	Overall rates of acute (within 48 hours post procedure) and near-term (between 2 and 30 days post procedure) serious complications in all GFA subjects compared to the acute and near-term treatment-related serious adverse event rates in the pivotal study.

Secondary Outcome Measures

Name	Time	Method
Assess the subject's general health outcome	60 months post procedure	General health outcome evaluation at 3, 6, 12, 24, 36, 48, and 60 months post procedure as compared to baseline using the EuroQol (EQ-5D), a standardized instrument for use as a measure of health outcome
Assess factors that influence indirect costs of the three treatment alternatives	60 months	Compare incidence costs of post discharge procedure-related complications and re-interventions we well as indirect cost factors defined as days to return-to-work, return to normal activities of daily living, and cost of care up to 60 months post discharge.
Assess subjects menstrual bleeding using the MIQ	60 months	Compare subjects menstrual bleeding pre-treatment and up to 3, 6, 12, 24, 36, 48, and 60 months post treatment using the Menorrhagia Impact Questionnaire (MIQ).
Assess Uterine Fibroid Symptom Severity and Quality of Life (UFS-QoL) pre-treatment to post treatment in all treatment groups	60 months	To compare fibroid symptom severity and quality of life scores at 3, 6, 12, 24, 36, 48, and 60 months post procedure as compared to baseline using the Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QoL) assessment tool.
Assess the incidence and cost of post discharge procedure-related complications and reinterventions	60 months	Safety measures will be assessed by comparing the complication and reintervention rate for all three alternatives (GFA, Myomectomy, UAE).
Assess subject's satisfaction with her treatment	12 months	Assess the subject's satisfaction with her assigned procedure at 12 months post procedure using the Overall Treatment Effect questionnaire
Assess the incidence of serious complications per investigator-surgeon during training and post training.	60 months	The incidence of acute and near-term serious complications following the GFA cases will also be analyzed by investigator-surgeon during the training and post training periods..

Trial Locations

Locations (9)

Augusta University; 🇺🇸 Augusta, Georgia, United States

University of Chicago Medicine and Biological Sciences; 🇺🇸 Chicago, Illinois, United States

University of California, Los Angeles; 🇺🇸 Santa Monica, California, United States

Brigham and Women's Hospital; 🇺🇸 Jamaica Plain, Massachusetts, United States

Henry Ford Hospital; 🇺🇸 West Bloomfield, Michigan, United States

INOVA; 🇺🇸 Falls Church, Virginia, United States

Aspen Surgery Center/John Muir Hospital; 🇺🇸 Walnut Creek, California, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

Texas Fertility Center; 🇺🇸 Austin, Texas, United States