Back to resultsEvaluation of the Endometrial Cavity After Endometrial Ablation (Postablation)
Primary Purpose
Menorrhagia
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Genesys HydroTherm Ablator
radiofrequency energy ablation device
Sponsored by
About this trial
This is an interventional treatment trial for Menorrhagia focused on measuring Endometrial ablation, menorrhagia
Eligibility Criteria
Inclusion Criteria:
- Premenopausal women Not pregnant and no future pregnancy desired Willing to randomize the device used for the ablation Willing to undergo diagnostic hysteroscopy with office-based anesthesia 6 months post-ablation
Exclusion Criteria:
- Pregnancy or desiring future pregnancy Endometrial hyperplasia Presence of active endometriosis Active pelvic inflammatory disease Previous endometrial ablation procedure
Sites / Locations
- Texas Health Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hydrothermal ablation
radiofrequency energy
Arm Description
Uterine ablation performed with a device that circulates heated water inside the uterus
ablation performed with a device that uses radiofrequency energy.
Outcomes
Primary Outcome Measures
Visualization of the inside of the uterus
The inside of the uterus will be visualized via hysteroscopy to determine the amount of scarring
Secondary Outcome Measures
Measurments of endometrial thickness
Measurements will be taken of the uterine cavity length and endometrial thickness
Full Information
NCT ID
NCT02087228
First Posted
March 10, 2014
Last Updated
January 15, 2016
Sponsor
Baylor Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02087228
Brief Title
Evaluation of the Endometrial Cavity After Endometrial Ablation
Acronym
Postablation
Official Title
Evaluation of the Endometrial Cavity After Endometrial Ablation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
Sponsor and Principle Investigator mutually agreed to terminate study and patients are no longer examined/treated
Study Start Date
September 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the shape, size and appearance of the inside of the uterus six months following an endometrial ablation procedure. Half of the participants will have their ablation performed with a hydrothermal ablation device and the other half will have their ablation performed with a device that uses radiofrequency energy.
Detailed Description
The purpose of this study is to evaluate the shape, size and appearance of the inside of the uterus six months following an endometrial ablation procedure. Half of the participants will have their ablation performed with a hydrothermal ablation device and the other half will have their ablation performed with a device that uses radiofrequency energy. Participants are randomly assigned to one or the other device.
A vaginal ultrasound will be performed before the procedure and again at six months post-procedure.
The inside of the uterus will be visualized via hysteroscopy before the procedure and again at six months post-procedure. Measurements will be taken and the investigator will compare photos taken pre-procedure and six months post-procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menorrhagia
Keywords
Endometrial ablation, menorrhagia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hydrothermal ablation
Arm Type
Experimental
Arm Description
Uterine ablation performed with a device that circulates heated water inside the uterus
Arm Title
radiofrequency energy
Arm Type
Active Comparator
Arm Description
ablation performed with a device that uses radiofrequency energy.
Intervention Type
Device
Intervention Name(s)
Genesys HydroTherm Ablator
Intervention Description
Heated water is circulated inside the uterus to destroy the lining of the uterus
Intervention Type
Device
Intervention Name(s)
radiofrequency energy ablation device
Primary Outcome Measure Information:
Title
Visualization of the inside of the uterus
Description
The inside of the uterus will be visualized via hysteroscopy to determine the amount of scarring
Time Frame
6 months post-ablation
Secondary Outcome Measure Information:
Title
Measurments of endometrial thickness
Description
Measurements will be taken of the uterine cavity length and endometrial thickness
Time Frame
6 months post-ablation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Premenopausal women Not pregnant and no future pregnancy desired Willing to randomize the device used for the ablation Willing to undergo diagnostic hysteroscopy with office-based anesthesia 6 months post-ablation
Exclusion Criteria:
Pregnancy or desiring future pregnancy Endometrial hyperplasia Presence of active endometriosis Active pelvic inflammatory disease Previous endometrial ablation procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Delbert A Johns, M.D.
Organizational Affiliation
Texas Health Care, Baylor Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Health Care
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Endometrial Cavity After Endometrial Ablation
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