Post Market TRUST - U.S.A. Study

Completed · Not applicable

Conditions studied: Symptomatic Uterine Fibroids

In brief

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.

Key facts

Study ID

NCT02163525

Run by

Acessa Health, Inc.

People needed

114

Starts

2014-06-12

Expected to finish

2025-09-12

Last updated by the study team

2025-09-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of California, Los Angeles — Santa Monica, California, United States
• Aspen Surgery Center/John Muir Hospital — Walnut Creek, California, United States
• Augusta University — Augusta, Georgia, United States
• University of Chicago Medicine and Biological Sciences — Chicago, Illinois, United States
• Brigham and Women's Hospital — Jamaica Plain, Massachusetts, United States
• Henry Ford Hospital — West Bloomfield, Michigan, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Texas Fertility Center — Austin, Texas, United States
• INOVA — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

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