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Post Market TRUST Study (TRUST)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01563783
Recruitment Status : Active, not recruiting
First Posted : March 27, 2012
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Acessa Health, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Uterine Fibroids Procedure: Global Fibroid Ablation (GFA) Procedure: Abdominal or Laparoscopic Myomectomy Procedure: Uterine Artery Embolization (UAE) Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Trust (Treatment Results of Uterine Sparing Technologies) Study
Study Start Date : December 2012
Actual Primary Completion Date : September 2017
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Uterine Fibroids

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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 ]
    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 :
  1. Assess the comparative safety of the three treatment alternatives [ Time Frame: 60 Months ]
    Safety measures will be assessed by comparing the complication rate for all three alternatives (GFA, Myomectomy, UAE).

  2. 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.

  3. Assess 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-QoL0 assessment tool.

  4. 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).

  5. Assess subject's satisfaction with her treatment [ Time Frame: 60 Months ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 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
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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): NCT01563783


Locations
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Canada, Saskatchewan
University of Saskatchewan, Saskatoon City Hospital
Saskatoon, Saskatchewan, Canada, S7K 0M7
Sponsors and Collaborators
Acessa Health, Inc.
Investigators
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Principal Investigator: John Thiel, MD Saskatchewan Health Authority - Regina Area
More Information
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Publications:
Macer JA. For uterine-sparing fibroid treatment, consider laparoscopic ultrasound-guided radiofrequency ablation. obmanagement.com Vol 25 No. 11 November 2013

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Responsible Party: Acessa Health, Inc.
ClinicalTrials.gov Identifier: NCT01563783    
Other Study ID Numbers: CP-00-0015
First Posted: March 27, 2012    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: January 2020
Keywords provided by Acessa Health, Inc.:
Fibroids
Myomas
leiomyomata
menorrhagia
 Acessa Procedure
Radiofrequency Ablation
RFA
Additional relevant MeSH terms:
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Leiomyoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms