The TRUST (Treatment Results of Uterine Sparing Technologies) Study

Study Purpose and Objectives

The purpose of this study is to evaluate the economic burden, safety and outcomes of three uterine-conserving treatment alternatives for symptomatic uterine fibroids: myomectomy, uterine artery embolization (UAE), and radiofrequency volumetric fibroid ablation using the Acessa™ System. 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.

Study Design

This is a post-market, randomized, prospective, multi-center, longitudinal, comparative study to evaluate the costs and health outcomes of the Acessa procedure vs the standard uterine conserving technologies (myomectomy and UAE) for the treatment of symptomatic uterine fibroids in women who desire uterine conservation.

  • Group 1 will consist of women who desire uterine preservation and who are candidates for myomectomy. Group 1 women will be randomized 1:1 to Acessa or myomectomy (laparoscopic or abdominal).
  • Group 2 will consist of women who desire uterine preservation but who are candidates for UAE. Group 2 women will be randomized 1:1 to Acessa or uterine artery embolization (UAE).

Sites may participate in Groups 1 and/or Group 2 depending on the availability of uterine conserving technologies and the local standard care pathway.

All eligible study subjects will be expected to continue participation in the study for 7 up tp 60 months following treatment. Subject participation will include evaluations pre-procedure (baseline), immediate post-procedure, and office or phone follow-up visits at 1 week and 4-8 weeks post treatment. Telephone follow up will occur at 24 to 72 hours post treatment. Questionnaires will be distributed at baseline, 3, 6, 12, 24, 36, 48, and 60 months post-procedure. Complications and reinterventions data will be collected for up to 60 months post treatment. Cost data pertaining to the treatment of the fibroids will be collected at the following time points: hospitalization (including the surgical procedure), post procedure recovery, and post discharge up to 60 months.

Inclusion Criteria: Women who:

  • 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: Women who:

  • 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 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 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.

 

If you are interested in learning more about this study, please refer to the clinicaltrials.gov website: http://www.clinicaltrials.gov/ct2/show/NCT02163525?term=Halt+medical&rank=5 (USA) or http://www.clinicaltrials.gov/ct2/show/NCT01563783?term+TRUST&rank=3 (Canada)

 

ClinicalTrials.gov Identifiers:
NCT02163525 and NCT01563783

 

 

LI-00-0211-E