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Completed

NCT Number: NCT02163525

Post Market TRUST - 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.

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Key information

Conditions

Symptomatic Uterine Fibroids Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Leiomyoma Menorrhagia Menstruation Disturbances Myoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Los Angeles, Santa Monica, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Global Fibroid Ablation (GFA)

Procedure

GFA is radiofrequency ablation of fibroids. This is a laparoscopic procedure whereby a radiofrequency probe is inserted into the fibroid under laparoscopic and ultrasound guidance. Each fibroid is heated to temperatures averaging 95 deg C. The fibroid undergoes coagulative necrosis and shrinks and/or disappears.

Other names: GFA, Radiofrequency ablation, RFA, Radiofrequency volumetric fibroid ablation, Acessa procedure, Acessa treatment

Abdominal or Laparoscopic Myomectomy

Procedure

Myomectomy is a procedure in which an incision is made into the uterus and the fibroids are surgically removed from the uterus. The uterine incision is closed with sutures. This procedure can be performed through an abdominal incision or via laparoscopy.

Other names: Myomectomy

Uterine artery embolization (UAE)

Procedure

UAE is a minimally invasive surgical procedure used to treat uterine fibroids. An embolic material is injected into the uterine artery(ies) to block blood flow to one or more fibroids. This procedure is performed by an interventional radiologist.

Other names: UAE, Uterine Fibroid Embolization, UFE

Primary outcomes

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

    Time frame: 3 months post procedure

    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.

  2. Compare rates of acute and near-term serious complications to the acute and near-term treatment-related serious adverse events of pivotal study.

    Time frame: 30 days post procedure

    Overall rates of acute (within 48 hours post procedure) and near-term (between 2 and 30 days post procedure) serious complications in all GFA subjects compared to the acute and near-term treatment-related serious adverse event rates in the pivotal study.

Secondary outcomes

  1. Assess the incidence and cost of post discharge procedure-related complications and reinterventions

    Time frame: 60 months

    Safety measures will be assessed by comparing the complication and reintervention rate for all three alternatives (GFA, Myomectomy, UAE).

  2. Assess factors that influence indirect costs of the three treatment alternatives

    Time frame: 60 months

    Compare incidence costs of post discharge procedure-related complications and re-interventions we well as indirect cost factors defined as days to return-to-work, return to normal activities of daily living, and cost of care up to 60 months post discharge.

  3. Assess Uterine Fibroid Symptom Severity and Quality of Life (UFS-QoL) pre-treatment to post treatment in all treatment groups

    Time frame: 60 months

    To compare fibroid symptom severity and quality of life scores at 3, 6, 12, 24, 36, 48, and 60 months post procedure as compared to baseline using the Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QoL) assessment tool.

  4. Assess subjects menstrual bleeding using the MIQ

    Time frame: 60 months

    Compare subjects menstrual bleeding pre-treatment and up to 3, 6, 12, 24, 36, 48, and 60 months post treatment using the Menorrhagia Impact Questionnaire (MIQ).

  5. Assess subject's satisfaction with her treatment

    Time frame: 12 months

    Assess the subject's satisfaction with her assigned procedure at 12 months post procedure using the Overall Treatment Effect questionnaire

  6. Assess the subject's general health outcome

    Time frame: 60 months post procedure

    General health outcome evaluation at 3, 6, 12, 24, 36, 48, and 60 months post procedure as compared to baseline using the EuroQol (EQ-5D), a standardized instrument for use as a measure of health outcome

  7. Assess the incidence of serious complications per investigator-surgeon during training and post training.

    Time frame: 60 months

    The incidence of acute and near-term serious complications following the GFA cases will also be analyzed by investigator-surgeon during the training and post training periods..

Sponsors and collaborators

Lead sponsor

Acessa Health, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2025
First posted
Jun 13, 2014
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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