Post Market TRUST - U.S.A. Study



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:8/12/2018
Start Date:June 2014
End Date:December 2023
Contact:Janine Little, BA
Email:jlittle@acessahealth.com

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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.

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.

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.
We found this trial at
9
sites
133 La Casa Via
Walnut Creek, California 94598
Principal Investigator: Yaron Friedman, MD
Phone: 925-478-7189
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Walnut Creek, CA
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Principal Investigator: Bala Bhagavath, MD
Phone: 585-275-9204
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Augusta, Georgia 30912
Principal Investigator: Kelli Braun, MD
Phone: 706-446-0014
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Augusta, GA
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Austin, Texas 78731
Principal Investigator: Kaylen Silverberg, MD
Phone: 512-610-7432
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Austin, TX
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Chicago, Illinois
Principal Investigator: Nathaniel Crump, MD
Phone: 773-834-5437
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Chicago, IL
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6565 Arlington Boulevard
Falls Church, Virginia 60637
Principal Investigator: S. Abb?s Shobeiri, MD
Phone: 703-776-7888
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Falls Church, VA
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30 Whitcomb Avenue
Jamaica Plain, Massachusetts 02130
Principal Investigator: James Greenberg, MD
Phone: 617-983-7003
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Jamaica Plain, MA
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405 Hilgard Avenue
Santa Monica, California 90404
Principal Investigator: Steve P Yu, MD
Phone: 310-206-6049
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Santa Monica, CA
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West Bloomfield, Michigan 48322
Principal Investigator: David Eisenstein, MD
Phone: 248-661-7381
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West Bloomfield, MI
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