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The Trust (Treatment Results of Uterine Sparing Technologies) Study

18 Years
Open (Enrolling)
Uterine Fibroids

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Trial Information

The Trust (Treatment Results of Uterine Sparing Technologies) Study

Uterine fibroids are the most common pelvic neoplasms in women; they severely impact quality
of life and are the leading indication for hysterectomy. Hysterectomy is the definitive
treatment for myomas; however, many patients seek alternative uterine-sparing therapy and
desire to conserve their fertility. Myomectomy is a much-reported surgical option for women
with symptomatic fibroids and, until recently, the abdominal approach has been the approach
of choice for most surgeons. Over time, patients have requested less invasive procedures and
minimally invasive, laparoscopic options are becoming more popular among patients and their
gynecologists. Standard surgical and interventional treatments for uterine fibroids are
costly to society and to the health care system. New technologies such as GFA may offer a
low-cost alternative to the standard treatments for symptomatic uterine fibroids in women
who desire uterine conservation. This study seeks to evaluate those cost differences between
three available uterine-sparing techniques and to explore the qualitative outcomes such as
symptom severity, health related quality of life, and overall treatment effect.

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 GnRh agonist within three months prior to the screening

- 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 or 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Compare direct cost of GFA compared to those of myomectomy and UAE

Outcome Description:

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.

Outcome Time Frame:

3 months post procedure

Safety Issue:


Principal Investigator

Togas Tulandi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

McGill University


Canada: Ethics Review Committee

Study ID:




Start Date:

December 2012

Completion Date:

December 2019

Related Keywords:

  • Uterine Fibroids
  • Fibroids
  • Myomas
  • leiomyomata
  • menorrhagia
  • Leiomyoma
  • Myofibroma