Post Market TRUST Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Trust (Treatment Results of Uterine Sparing Technologies) Study

Conditions
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Uterine Fibroids

Intervention / Treatment
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* Procedure: Global Fibroid Ablation (GFA)
* Procedure: Abdominal or Laparoscopic Myomectomy
* Procedure: Uterine Artery Embolization (UAE)


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Woman Suitable for Myomectomy or GFA<br>This group will consist of women who desire uterine preservation. Women will be randomized 1:1 to GFA or Myomectomy (laparoscopic or abdominal). | Procedure: Global Fibroid Ablation (GFA)<br>* GFA is being used for the treatment of symptomatic uterine fibroids<br>* Other names: GFA;Procedure: Abdominal or Laparoscopic Myomectomy<br>* Myomectomy is a procedure in which uterine fibroids are surgically removed from the uterus.<br>* Other names: Myomectomy;|
| Active Comparator: Woman Suitable for UAE or GFA<br>This group will consist of women who desire uterine preservation. Women will be randomized 1:1 to GFA or uterine artery embolization (UAE). | Procedure: Global Fibroid Ablation (GFA)<br>* GFA is being used for the treatment of symptomatic uterine fibroids<br>* Other names: GFA;Procedure: Uterine Artery Embolization (UAE)<br>* UAE is a minimally invasive surgical procedure used to treat uterine fibroids.<br>* Other names: UAE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare direct cost of GFA compared to those of myomectomy and UAE | 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. | 3 months post procedure | 
| Compare rates of acute and near-term serious complications to the acute and near-term treatment-related serious adverse events of pivotal study. | 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. | 3 months post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the comparative safety of the three treatment alternatives | Safety measures will be assessed by comparing the complication rate for all three alternatives (GFA, Myomectomy, UAE). | 60 Months | 
| Assess factors that influence indirect costs of the three treatment alternatives | 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. | 60 Months | 
| Assess UFS-QoL pre-treatment to post treatment in all treatment groups | 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-QoL0 assessment tool. | 60 Months | 
| Assess subjects menstrual bleeding using the MIQ | 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). | 60 Months | 
| Assess subject's satisfaction with her treatment | Compare subject's satisfaction and general health outcome at 3, 6, 12, 24, 36, 48, and 60 months post procedure as compared to baseline using the EQ-5D (a standardized instrument for use as a measure of health outcome). | 60 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibroids, Myomas, leiomyomata, menorrhagia, Acessa Procedure, Radiofrequency Ablation, RFA