Registry Study of Genesys HTA for Treatment of Menorrhagia
This study has been completed.
Sponsor:
Boston Scientific Corporation
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01197547
First received: September 1, 2010
Last updated: February 4, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Menorrhagia |
Device: Genesys HTA |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Genesys HTA Post Approval Registry A Multi-center, Single-arm, Prospective Registry of the Genesys HTA System for the Treatment of Menorrhagia |
Further study details as provided by Boston Scientific Corporation:
Primary Outcome Measures:
- Burn rate [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Technical malfunctions and SADEs [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
| Enrollment: | 1014 |
| Study Start Date: | November 2010 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Genesys HTA
Genesys HTA Endometrial Ablation
|
Device: Genesys HTA
Genesys HTA Endometrial Ablation
Other Name: Genesys HTA Endometrial Ablation
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject must meet the approved indication for use to be considered for this registry.
Exclusion Criteria:
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197547
Locations
| United States, California | |
| Sharp Mary Birch | |
| San Diego, California, United States, 92123 | |
| United States, Delaware | |
| Christiana Hospital | |
| Newark, Delaware, United States, 19718 | |
| United States, Georgia | |
| Shelnutt Obstetrics and Gynecology | |
| Athens, Georgia, United States, 30606 | |
| United States, Kentucky | |
| Health South Surgecenter of Louisville | |
| Louisville, Kentucky, United States, 40207 | |
| United States, Michigan | |
| Wayne State University Physician Group | |
| Southfield, Michigan, United States, 48034 | |
| United States, Ohio | |
| Seven Hills OB GYN Associates | |
| Cincinnati, Ohio, United States, 45201 | |
| Complete Healthcare for Women | |
| Columbus, Ohio, United States, 43213 | |
| United States, Pennsylvania | |
| Associates in Women's Healthcare | |
| Philadelphia, Pennsylvania, United States, 19115 | |
| Schuykill Medical Center South | |
| Pottsville, Pennsylvania, United States, 17901 | |
| United States, Tennessee | |
| Chattanooga Medical Research | |
| Chattanooga, Tennessee, United States, 37404 | |
| State of Franklin Healthcare Associates | |
| Johnson City, Tennessee, United States, 37604 | |
| United States, Texas | |
| Associates in Obstetrics and Gynecology | |
| Bedford, Texas, United States, 76021 | |
| Central Womens Care PA | |
| Dallas, Texas, United States, 75231 | |
| Doreen Moser, DO | |
| Grapevine, Texas, United States, 76051 | |
| MacArthur OBGYN | |
| Irving, Texas, United States, 75062 | |
| Personalized Women's Healthcare | |
| Plano, Texas, United States, 75093 | |
| United States, Utah | |
| Ogden Clinic | |
| Ogden, Utah, United States, 84403 | |
| Old Farm Obstetrics and Gynecology | |
| Salt Lake City, Utah, United States, 84107 | |
| United States, Wisconsin | |
| Milwaukee ObGyn | |
| Milwaukee, Wisconsin, United States, 53221 | |
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
| Study Director: | Thomas Bowman, M.D. | Boston Scientific Corporation |
More Information
No publications provided
| Responsible Party: | Boston Scientific Corporation |
| ClinicalTrials.gov Identifier: | NCT01197547 History of Changes |
| Other Study ID Numbers: | U8088 |
| Study First Received: | September 1, 2010 |
| Last Updated: | February 4, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Boston Scientific Corporation:
|
Menorrhagia |
Additional relevant MeSH terms:
|
Menorrhagia Uterine Hemorrhage Uterine Diseases |
Genital Diseases, Female Menstruation Disturbances Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013