Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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.

Official Title

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

Details

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.

Keywords

Symptomatic Uterine Fibroids Fibroids Myomas leiomyomata menorrhagia Acessa Procedure Radiofrequency Ablation (RFA) GFA Acessa Leiomyoma Global Fibroid Ablation (GFA) Abdominal or Laparoscopic Myomectomy Uterine Artery Embolization (UAE) Ablation vs Embolization Ablation vs Myomectomy

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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 CAN'T join 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.

Locations

  • University of California, Los Angeles
    Santa Monica California 90401 United States
  • Aspen Surgery Center/John Muir Hospital
    Walnut Creek California 94598 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Acessa Health, Inc.
ID
NCT02163525
Study Type
Interventional
Participants
At least 114 people participating
Last Updated