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Procedure

Woman Suitable for UAE or GFA for Uterine Fibroids (TRUST Trial)

N/A
Waitlist Available
Led By John Thiel, MD
Research Sponsored by Acessa Health, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Are ≥ 18 years old and menstruating
Have symptomatic uterine fibroids
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights

TRUST Trial 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.

Eligible Conditions
  • Uterine Fibroids

TRUST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

TRUST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Uterine Myomectomy
Compare rates of acute and near-term serious complications to the acute and near-term treatment-related serious adverse events of pivotal study.
Secondary outcome measures
Assess UFS-QoL pre-treatment to post treatment in all treatment groups
Assess factors that influence indirect costs of the three treatment alternatives
Therapeutic procedure
+2 more

TRUST Trial Design

2Treatment groups
Active Control
Group I: Woman Suitable for UAE or GFAActive Control2 Interventions
This group will consist of women who desire uterine preservation. Women will be randomized 1:1 to GFA or uterine artery embolization (UAE).
Group II: Woman Suitable for Myomectomy or GFAActive Control2 Interventions
This group will consist of women who desire uterine preservation. Women will be randomized 1:1 to GFA or Myomectomy (laparoscopic or abdominal).

Find a Location

Who is running the clinical trial?

Acessa Health, Inc.Lead Sponsor
4 Previous Clinical Trials
320 Total Patients Enrolled
John Thiel, MDPrincipal InvestigatorSaskatchewan Health Authority - Regina Area

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
~7 spots leftby Mar 2025