Post Market TRUST - U.S.A. 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. 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.

Detailed Description
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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.

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

Conditions
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Symptomatic 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 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.

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: Ablation vs Embolization<br>Women are randomized 1:1 to either global fibroid ablation (GFA) or uterine artery embolization (UAE) | Procedure: Global Fibroid Ablation (GFA)<br>* 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.<br>* Other names: Acessa treatment;Procedure: Uterine Artery Embolization (UAE)<br>* 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.<br>* Other names: UFE;|
| Active Comparator: Ablation vs Myomectomy<br>Women are randomized 1:1 to either global fibroid ablation (GFA) or myomectomy (laparoscopic or abdominal) | Procedure: Global Fibroid Ablation (GFA)<br>* 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.<br>* Other names: Acessa treatment;Procedure: Abdominal or Laparoscopic Myomectomy<br>* 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.<br>* Other names: Myomectomy;|

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. | 30 days post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the incidence and cost of post discharge procedure-related complications and reinterventions | Safety measures will be assessed by comparing the complication and reintervention 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 Uterine Fibroid Symptom Severity and Quality of Life (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-QoL) 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 | Assess the subject's satisfaction with her assigned procedure at 12 months post procedure using the Overall Treatment Effect questionnaire | 12 months | 
| Assess the subject's general health outcome | 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 | 60 months post procedure | 
| Assess the incidence of serious complications per investigator-surgeon during training and post training. | 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.. | 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), GFA, Acessa