Post Market TRUST - U.S.A. Study

September 7, 2023 updated by: Acessa Health, Inc.

The TRUST (Treatment Results of Uterine Sparing Technologies) U.S.A. Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90401
        • University of California, Los Angeles
      • Walnut Creek, California, United States, 94598
        • Aspen Surgery Center/John Muir Hospital
    • Georgia
      • Augusta, Georgia, United States, 30912-3360
        • Augusta University
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medicine and Biological Sciences
    • Massachusetts
      • Jamaica Plain, Massachusetts, United States, 02130
        • Brigham and Women's Hospital
    • Michigan
      • West Bloomfield, Michigan, United States, 48322
        • Henry Ford Hospital
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • Texas
      • Austin, Texas, United States, 78731
        • Texas Fertility Center
    • Virginia
      • Falls Church, Virginia, United States, 60637
        • Inova

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ablation vs Embolization
Women are randomized 1:1 to either global fibroid ablation (GFA) or uterine artery embolization (UAE)
Procedure: Global Fibroid Ablation (GFA)
GFA is radiofrequency ablation of fibroids. This is a laparoscopic procedure whereby a radiofrequency probe is inserted into the fibroid under laparoscopic and ultrasound guidance. Each fibroid is heated to temperatures averaging 95 deg C. The fibroid undergoes coagulative necrosis and shrinks and/or disappears.
Other Names:
  • RFA
  • Radiofrequency ablation
  • GFA
  • Radiofrequency volumetric fibroid ablation
  • Acessa procedure
  • Acessa treatment
Procedure: Uterine Artery Embolization (UAE)
UAE is a minimally invasive surgical procedure used to treat uterine fibroids. An embolic material is injected into the uterine artery(ies) to block blood flow to one or more fibroids. This procedure is performed by an interventional radiologist.
Other Names:
  • UAE
  • Uterine Fibroid Embolization
  • UFE
Active Comparator: Ablation vs Myomectomy
Women are randomized 1:1 to either global fibroid ablation (GFA) or myomectomy (laparoscopic or abdominal)
Procedure: Global Fibroid Ablation (GFA)
GFA is radiofrequency ablation of fibroids. This is a laparoscopic procedure whereby a radiofrequency probe is inserted into the fibroid under laparoscopic and ultrasound guidance. Each fibroid is heated to temperatures averaging 95 deg C. The fibroid undergoes coagulative necrosis and shrinks and/or disappears.
Other Names:
  • RFA
  • Radiofrequency ablation
  • GFA
  • Radiofrequency volumetric fibroid ablation
  • Acessa procedure
  • Acessa treatment
Procedure: Abdominal or Laparoscopic Myomectomy
Myomectomy is a procedure in which an incision is made into the uterus and the fibroids are surgically removed from the uterus. The uterine incision is closed with sutures. This procedure can be performed through an abdominal incision or via laparoscopy.
Other Names:
  • Myomectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare direct cost of GFA compared to those of myomectomy and UAE
Time Frame: 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.
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.
Time Frame: 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.
30 days post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the incidence and cost of post discharge procedure-related complications and reinterventions
Time Frame: 60 months
Safety measures will be assessed by comparing the complication and reintervention rate for all three alternatives (GFA, Myomectomy, UAE).
60 months
Assess factors that influence indirect costs of the three treatment alternatives
Time Frame: 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.
60 months
Assess Uterine Fibroid Symptom Severity and Quality of Life (UFS-QoL) pre-treatment to post treatment in all treatment groups
Time Frame: 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.
60 months
Assess subjects menstrual bleeding using the MIQ
Time Frame: 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).
60 months
Assess subject's satisfaction with her treatment
Time Frame: 12 months
Assess the subject's satisfaction with her assigned procedure at 12 months post procedure using the Overall Treatment Effect questionnaire
12 months
Assess the subject's general health outcome
Time Frame: 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
60 months post procedure
Assess the incidence of serious complications per investigator-surgeon during training and post training.
Time Frame: 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..
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acessa Health, Inc.

Investigators

  • Study Director: David Eisenstein, MD, Henry Ford Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

July 1, 2019

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

June 11, 2014

First Submitted That Met QC Criteria

June 11, 2014

First Posted (Estimated)

June 13, 2014

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-00-0025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Symptomatic Uterine Fibroids

Clinical Trials on Global Fibroid Ablation (GFA)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe