Registry Study of Genesys HTA for Treatment of Menorrhagia
Genesys HTA
Genesys HTA Post Approval Registry A Multi-center, Single-arm, Prospective Registry of the Genesys HTA System for the Treatment of Menorrhagia
1 other identifier
interventional
1,014
1 country
19
Brief Summary
This is a clinical registry of an FDA approved device system called the Genesys Hydro ThermAblatorTM (HTA) system (Boston Scientific). The HTA system's intended use is to be inserted, by a trained physician, into the uterus, where it will fill and circulate fluid that is warm enough to change the characteristics of the uterine lining. This is done with the anticipated result of improving menstrual bleeding symptoms. The purpose of this FDA-mandated registry is to obtain clinical experience on the use the Genesys HTA™ system, under normal clinical conditions, and document its safety and technical reliability.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2010
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2010
CompletedFirst Posted
Study publicly available on registry
September 9, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
May 17, 2017
CompletedMarch 26, 2021
April 1, 2017
1.3 years
September 1, 2010
June 7, 2016
March 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Burn Rate
Day 1
Secondary Outcomes (2)
Technical Malfunctions
Day 1
Serious Adverse Device Effect (SADE)
Day 1
Study Arms (1)
Genesys HTA
OTHERGenesys HTA Endometrial Ablation
Interventions
Genesys HTA Endometrial Ablation
Eligibility Criteria
You may qualify if:
- Subject must meet the approved indication for use to be considered for this registry.
You may not qualify if:
- All subjects contraindicated for the treatment of the Genesys HTA System per the Directions for Use will be excluded:
- The subject is pregnant or wants to be pregnant in the future
- The subject has known or suspected endometrial carcinoma or premalignant change of the endometrium, such as adenomatous hyperplasia
- The subject has active pelvic inflammatory disease or pyosalpinx
- The subject has hydrosalpinx
- The subject in whom a tight cervical seal cannot be established and maintained around the procedure sheath
- The subject has an anatomical condition (e.g. history of previous classical cesarean section or transmural myomectomy) or pathologic condition (e.g. long term medical therapy) that could lead to weakening of the myometrium
- The subject has an intrauterine device in place
- The subject has an active genital or urinary tract infection (e.g. cervicitis, endometritis, vaginitis, cystitis, etc.) at the time of treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Sharp Mary Birch
San Diego, California, 92123, United States
Christiana Hospital
Newark, Delaware, 19718, United States
Shelnutt Obstetrics and Gynecology
Athens, Georgia, 30606, United States
Health South Surgecenter of Louisville
Louisville, Kentucky, 40207, United States
Wayne State University Physician Group
Southfield, Michigan, 48034, United States
Seven Hills OB GYN Associates
Cincinnati, Ohio, 45201, United States
Complete Healthcare for Women
Columbus, Ohio, 43213, United States
Associates in Women's Healthcare
Philadelphia, Pennsylvania, 19115, United States
Schuykill Medical Center South
Pottsville, Pennsylvania, 17901, United States
Chattanooga Medical Research
Chattanooga, Tennessee, 37404, United States
State of Franklin Healthcare Associates
Johnson City, Tennessee, 37604, United States
Associates in Obstetrics and Gynecology
Bedford, Texas, 76021, United States
Central Womens Care PA
Dallas, Texas, 75231, United States
Doreen Moser, DO
Grapevine, Texas, 76051, United States
MacArthur OBGYN
Irving, Texas, 75062, United States
Personalized Women's Healthcare
Plano, Texas, 75093, United States
Ogden Clinic
Ogden, Utah, 84403, United States
Old Farm Obstetrics and Gynecology
Salt Lake City, Utah, 84107, United States
Milwaukee ObGyn
Milwaukee, Wisconsin, 53221, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Meaghan Wilk
- Organization
- Boston Scientific
Study Officials
- STUDY DIRECTOR
Thomas Bowman, M.D.
Boston Scientific Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2010
First Posted
September 9, 2010
Study Start
November 1, 2010
Primary Completion
February 1, 2012
Study Completion
August 1, 2012
Last Updated
March 26, 2021
Results First Posted
May 17, 2017
Record last verified: 2017-04