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Post Market TRUST - U.S.A. Study

Primary Purpose

Symptomatic Uterine Fibroids

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Global Fibroid Ablation (GFA)
Abdominal or Laparoscopic Myomectomy
Uterine Artery Embolization (UAE)
Sponsored by
Acessa Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Uterine Fibroids focused on measuring Fibroids, Myomas, leiomyomata, menorrhagia, Acessa Procedure, Radiofrequency Ablation (RFA), GFA, Acessa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, Los Angeles
  • Aspen Surgery Center/John Muir Hospital
  • Augusta University
  • University of Chicago Medicine and Biological Sciences
  • Brigham and Women's Hospital
  • Henry Ford Hospital
  • University of Rochester Medical Center
  • Texas Fertility Center
  • INOVA

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ablation vs Embolization

Ablation vs Myomectomy

Arm Description

Women are randomized 1:1 to either global fibroid ablation (GFA) or uterine artery embolization (UAE)

Women are randomized 1:1 to either global fibroid ablation (GFA) or myomectomy (laparoscopic or abdominal)

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).
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.
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.
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).
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
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
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..

Full Information

First Posted
June 11, 2014
Last Updated
September 7, 2023
Sponsor
Acessa Health, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02163525
Brief Title
Post Market TRUST - U.S.A. Study
Official Title
The TRUST (Treatment Results of Uterine Sparing Technologies) U.S.A. Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2014 (undefined)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acessa Health, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Uterine Fibroids
Keywords
Fibroids, Myomas, leiomyomata, menorrhagia, Acessa Procedure, Radiofrequency Ablation (RFA), GFA, Acessa

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ablation vs Embolization
Arm Type
Active Comparator
Arm Description
Women are randomized 1:1 to either global fibroid ablation (GFA) or uterine artery embolization (UAE)
Arm Title
Ablation vs Myomectomy
Arm Type
Active Comparator
Arm Description
Women are randomized 1:1 to either global fibroid ablation (GFA) or myomectomy (laparoscopic or abdominal)
Intervention Type
Procedure
Intervention Name(s)
Global Fibroid Ablation (GFA)
Other Intervention Name(s)
GFA, Radiofrequency ablation, RFA, Radiofrequency volumetric fibroid ablation, Acessa procedure, Acessa treatment
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Abdominal or Laparoscopic Myomectomy
Other Intervention Name(s)
Myomectomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Uterine Artery Embolization (UAE)
Other Intervention Name(s)
UAE, Uterine Fibroid Embolization, UFE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Compare direct cost of GFA compared to those of myomectomy and UAE
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.
Time Frame
3 months post procedure
Title
Compare rates of acute and near-term serious complications to the acute and near-term treatment-related serious adverse events of pivotal study.
Description
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.
Time Frame
30 days post procedure
Secondary Outcome Measure Information:
Title
Assess the incidence and cost of post discharge procedure-related complications and reinterventions
Description
Safety measures will be assessed by comparing the complication and reintervention rate for all three alternatives (GFA, Myomectomy, UAE).
Time Frame
60 months
Title
Assess factors that influence indirect costs of the three treatment alternatives
Description
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.
Time Frame
60 months
Title
Assess Uterine Fibroid Symptom Severity and Quality of Life (UFS-QoL) pre-treatment to post treatment in all treatment groups
Description
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.
Time Frame
60 months
Title
Assess subjects menstrual bleeding using the MIQ
Description
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).
Time Frame
60 months
Title
Assess subject's satisfaction with her treatment
Description
Assess the subject's satisfaction with her assigned procedure at 12 months post procedure using the Overall Treatment Effect questionnaire
Time Frame
12 months
Title
Assess the subject's general health outcome
Description
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
Time Frame
60 months post procedure
Title
Assess the incidence of serious complications per investigator-surgeon during training and post training.
Description
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..
Time Frame
60 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Eisenstein, MD
Organizational Affiliation
Henry Ford Hospital
Official's Role
Study Director
Facility Information:
Facility Name
University of California, Los Angeles
City
Santa Monica
State/Province
California
ZIP/Postal Code
90401
Country
United States
Facility Name
Aspen Surgery Center/John Muir Hospital
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912-3360
Country
United States
Facility Name
University of Chicago Medicine and Biological Sciences
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Brigham and Women's Hospital
City
Jamaica Plain
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Facility Name
Henry Ford Hospital
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Texas Fertility Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
INOVA
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
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Post Market TRUST - U.S.A. Study

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