Back to resultsPost Market TRUST Study (TRUST)
Primary Purpose
Uterine Fibroids
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Global Fibroid Ablation (GFA)
Abdominal or Laparoscopic Myomectomy
Uterine Artery Embolization (UAE)
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Fibroids focused on measuring Fibroids, Myomas, leiomyomata, menorrhagia, Acessa Procedure, Radiofrequency Ablation, RFA
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 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 Saskatchewan, Saskatoon City Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Woman Suitable for Myomectomy or GFA
Woman Suitable for UAE or GFA
Arm Description
This group will consist of women who desire uterine preservation. Women will be randomized 1:1 to GFA or Myomectomy (laparoscopic or abdominal).
This group will consist of women who desire uterine preservation. Women will be randomized 1:1 to GFA or uterine artery embolization (UAE).
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 comparative safety of the three treatment alternatives
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
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
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
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
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01563783
Brief Title
Post Market TRUST Study
Acronym
TRUST
Official Title
The Trust (Treatment Results of Uterine Sparing Technologies) Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
June 2022 (Actual)
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids
Keywords
Fibroids, Myomas, leiomyomata, menorrhagia, Acessa Procedure, Radiofrequency Ablation, RFA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Woman Suitable for Myomectomy or GFA
Arm Type
Active Comparator
Arm Description
This group will consist of women who desire uterine preservation. Women will be randomized 1:1 to GFA or Myomectomy (laparoscopic or abdominal).
Arm Title
Woman Suitable for UAE or GFA
Arm Type
Active Comparator
Arm Description
This group will consist of women who desire uterine preservation. Women will be randomized 1:1 to GFA or uterine artery embolization (UAE).
Intervention Type
Procedure
Intervention Name(s)
Global Fibroid Ablation (GFA)
Other Intervention Name(s)
GFA
Intervention Description
GFA is being used for the treatment of symptomatic uterine fibroids
Intervention Type
Procedure
Intervention Name(s)
Abdominal or Laparoscopic Myomectomy
Other Intervention Name(s)
Myomectomy
Intervention Description
Myomectomy is a procedure in which uterine fibroids are surgically removed from the uterus.
Intervention Type
Procedure
Intervention Name(s)
Uterine Artery Embolization (UAE)
Other Intervention Name(s)
UAE
Intervention Description
UAE is a minimally invasive surgical procedure used to treat uterine fibroids.
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
3 months post procedure
Secondary Outcome Measure Information:
Title
Assess the comparative safety of the three treatment alternatives
Description
Safety measures will be assessed by comparing the complication 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 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-QoL0 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
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).
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 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
John Thiel, MD
Organizational Affiliation
Saskatchewan Health Authority - Regina Area
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Saskatchewan, Saskatoon City Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 0M7
Country
Canada
12. IPD Sharing Statement
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Post Market TRUST Study
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