Post Market TRUST Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Halt Medical, Inc
Sponsor:
Information provided by (Responsible Party):
Halt Medical, Inc
ClinicalTrials.gov Identifier:
NCT01563783
First received: March 22, 2012
Last updated: May 16, 2014
Last verified: May 2014
  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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Trust (Treatment Results of Uterine Sparing Technologies) Study

Resource links provided by NLM:


Further study details as provided by Halt Medical, Inc:

Primary Outcome Measures:
  • Compare direct cost of GFA compared to those of myomectomy and UAE [ Time Frame: 3 months post procedure ] [ Designated as safety issue: No ]
    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: 3 months post procedure ] [ Designated as safety issue: No ]
    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 comparative safety of the three treatment alternatives [ Time Frame: 60 Months ] [ Designated as safety issue: Yes ]
    Safety measures will be assessed by comparing the complication rate for all three alternatives (GFA, Myomectomy, UAE).

  • Assess factors that influence indirect costs of the three treatment alternatives [ Time Frame: 60 Months ] [ Designated as safety issue: No ]
    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 UFS-QoL pre-treatment to post treatment in all treatment groups [ Time Frame: 60 Months ] [ Designated as safety issue: No ]
    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.

  • Assess subjects menstrual bleeding using the MIQ [ Time Frame: 60 Months ] [ Designated as safety issue: No ]
    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: 60 Months ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 260
Study Start Date: December 2012
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Woman Suitable for Myomectomy or GFA
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)
GFA is being used for the treatment of symptomatic uterine fibroids
Other Name: GFA
Procedure: Abdominal or Laparoscopic Myomectomy
Myomectomy is a procedure in which uterine fibroids are surgically removed from the uterus.
Other Name: Myomectomy
Active Comparator: Woman Suitable for UAE or GFA
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)
GFA is being used for the treatment of symptomatic uterine fibroids
Other Name: GFA
Procedure: Uterine Artery Embolization (UAE)
UAE is a minimally invasive surgical procedure used to treat uterine fibroids.
Other Name: UAE

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01563783

Contacts
Contact: Laura Kemp 408-375-1465 lkemp@haltmedical.com
Contact: Sarah Good, BS 925-348-9910 sgood@haltmedical.com

Locations
Canada, British Columbia
British Columbia Women's Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z4E1
Contact: Ariadna Fernandez    604-875-2979    afernandez@cw.bc.ca   
Contact: Nancy Makela       nancymakela@gmail.com   
Principal Investigator: Barry Sanders, MD         
Canada, Ontario
McMasters University Medical Center Active, not recruiting
Hamilton, Ontario, Canada, L8N3Z5
Canada, Saskatchewan
Regina General Hospital Recruiting
Regina, Saskatchewan, Canada, S4P0W5
Contact: Shan Thiel       sthielwing@aol.com   
Contact: Kelly Phillips       kellydphillips@gmail.com   
Principal Investigator: John Thiel, MD         
Sub-Investigator: Darrien Rattray, MD         
Sponsors and Collaborators
Halt Medical, Inc
Investigators
Principal Investigator: Nicholas Leyland, MD McMasters University Medical Center
Principal Investigator: Barry Sanders, MD British Columbia Women's Hospital
Principal Investigator: John Thiel, MD Regina Qu'Appelle Health Region
  More Information

Publications:

Responsible Party: Halt Medical, Inc
ClinicalTrials.gov Identifier: NCT01563783     History of Changes
Other Study ID Numbers: CP-00-0015
Study First Received: March 22, 2012
Last Updated: May 16, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Halt Medical, Inc:
Fibroids
Myomas
leiomyomata
menorrhagia
Acessa Procedure
Radiofrequency Ablation
RFA

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

ClinicalTrials.gov processed this record on September 16, 2014