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Post Market TRUST - U.S.A. Study

This study is currently recruiting participants.
Verified August 2017 by Acessa Health, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02163525
First Posted: June 13, 2014
Last Update Posted: August 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Acessa Health, Inc.
  Purpose
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.

Condition Intervention
Symptomatic Uterine Fibroids Procedure: Global Fibroid Ablation (GFA) Procedure: Abdominal or Laparoscopic Myomectomy Procedure: Uterine Artery Embolization (UAE)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The TRUST (Treatment Results of Uterine Sparing Technologies) U.S.A. Study

Resource links provided by NLM:


Further study details as provided by Acessa Health, Inc.:

Primary Outcome Measures:
  • 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.

  • 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 Outcome Measures:
  • 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).

  • 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.

  • 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.

  • 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).

  • 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

  • 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

  • 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..


Estimated Enrollment: 300
Study Start Date: June 2014
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ablation vs Embolization
Women are randomized 1:1 to either global fibroid ablation (GFA) or uterine artery embolization (UAE)
Procedure: Global Fibroid Ablation (GFA)
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
Procedure: Uterine Artery Embolization (UAE)
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
Active Comparator: Ablation vs Myomectomy
Women are randomized 1:1 to either global fibroid ablation (GFA) or myomectomy (laparoscopic or abdominal)
Procedure: Global Fibroid Ablation (GFA)
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
Procedure: Abdominal or Laparoscopic Myomectomy
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 Name: Myomectomy

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163525


Contacts
Contact: Janine Little, BA jlittle@acessahealth.com
Contact: Laura Kemp, BS,MA,RT(R) lkemp@acessahealth.com

Locations
United States, California
University of California, Los Angeles Recruiting
Santa Monica, California, United States, 90401
Contact: Ria Jain, BS    310-206-6049    riajain@mednet.ucla.edu   
Contact: Anna Amamchyan, BS    310-825-5255    aamamchyan@mednet.ucla.edu   
Principal Investigator: Steve P Yu, MD         
Aspen Surgery Center/John Muir Hospital Recruiting
Walnut Creek, California, United States, 94598
Contact: Julie Pascualy, P.A.    925-478-7189    julie.truststudy@gmail.com   
Principal Investigator: Yaron Friedman, MD         
Sub-Investigator: Donald Galen, MD         
United States, Georgia
Augusta University Recruiting
Augusta, Georgia, United States, 30912-3360
Contact: Julie Miller, LPN    706-446-0014    JMILLER7@augusta.edu   
Contact: Connie Edwards, RN    706-446-0014    COEDWARDS@augusta.edu   
Principal Investigator: Kelli Braun, MD         
Sub-Investigator: Erin Latif, MD         
Sub-Investigator: Chad Ray, MD         
Sub-Investigator: Manish Jain, MD         
United States, Illinois
University of Chicago Medicine and Biological Sciences Recruiting
Chicago, Illinois, United States, 60637
Contact: Katherine Lewis, MS    773-834-5437    KLewis2@bsd.uchicago.edu   
Contact: Danielle Young, MPH    773-834-0171    DYoung1@bsd.uchicago.edu   
Principal Investigator: Nathaniel Crump, MD         
Sub-Investigator: Laura Douglass, MD         
Sub-Investigator: Perpetua Goodall, MD         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Jamaica Plain, Massachusetts, United States, 02130
Contact: James Greenberg, MD    617-983-7003    jagreenberg@bwh.harvard.edu   
Principal Investigator: James Greenberg, MD         
United States, Michigan
Henry Ford Hospital Recruiting
West Bloomfield Township, Michigan, United States, 48322
Contact: David Eisenstein, MD    248-661-7381    Deisens1@hfhs.org   
Principal Investigator: David Eisenstein, MD         
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Divya Kumar, MPH    585-275-9204    Divya_Kumar@URMC.Rochester.edu   
Contact: Bala Bhagavath, MD    585-487-3445      
Principal Investigator: Bala Bhagavath, MD         
United States, Texas
Texas Fertility Center Recruiting
Austin, Texas, United States, 78731
Contact: Tamara Minter    512-610-7432    tamara@txfertility.com   
Principal Investigator: Kaylen Silverberg, MD         
Sub-Investigator: Anthony Propst, MD         
Sub-Investigator: Lisa Hansard, MD         
Sub-Investigator: Thomas Vaughn, MD         
United States, Virginia
INOVA Recruiting
Falls Church, Virginia, United States, 60637
Contact: Rashmi Mishra, MD    703-776-4600    rashmi.mishra@inova.org   
Contact: Stephanie Marull    703-776-4345    stephanie.marull@inova.org   
Principal Investigator: S. Abbās Shobeiri, MD         
Sponsors and Collaborators
Acessa Health, Inc.
Investigators
Study Director: David Eisenstein, MD Henry Ford Hospital
  More Information

Publications:
Macer JA. For uterine-sparing fibroid treatment, consider laparoscopic ultrasound-guided radiofrequency ablation. obmanagement.com Vol 25 No. 11 November 2013

Responsible Party: Acessa Health, Inc.
ClinicalTrials.gov Identifier: NCT02163525     History of Changes
Other Study ID Numbers: CP-00-0025
First Submitted: June 11, 2014
First Posted: June 13, 2014
Last Update Posted: August 9, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Acessa Health, Inc.:
Fibroids
Myomas
leiomyomata
menorrhagia
Acessa Procedure
Radiofrequency Ablation (RFA)
GFA
Acessa

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases