Registry Study of Genesys HTA for Treatment of Menorrhagia
Public ClinicalTrials.gov record NCT01197547. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Genesys HTA Post Approval Registry A Multi-center, Single-arm, Prospective Registry of the Genesys HTA System for the Treatment of Menorrhagia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01197547
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1,014 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2010 (Type not available)
- Primary completion
- Feb 2012 (Actual)
- Completion
- Aug 2012 (Actual)
- Last update posted
- Mar 26, 2021
2010 – 2012
United States locations
- U.S. sites
- 19
- U.S. states
- 11
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sharp Mary Birch | San Diego | California | 92123 | — |
| Christiana Hospital | Newark | Delaware | 19718 | — |
| Shelnutt Obstetrics and Gynecology | Athens | Georgia | 30606 | — |
| Health South Surgecenter of Louisville | Louisville | Kentucky | 40207 | — |
| Wayne State University Physician Group | Southfield | Michigan | 48034 | — |
| Seven Hills OB GYN Associates | Cincinnati | Ohio | 45201 | — |
| Complete Healthcare for Women | Columbus | Ohio | 43213 | — |
| Associates in Women's Healthcare | Philadelphia | Pennsylvania | 19115 | — |
| Schuykill Medical Center South | Pottsville | Pennsylvania | 17901 | — |
| Chattanooga Medical Research | Chattanooga | Tennessee | 37404 | — |
| State of Franklin Healthcare Associates | Johnson City | Tennessee | 37604 | — |
| Associates in Obstetrics and Gynecology | Bedford | Texas | 76021 | — |
| Central Womens Care PA | Dallas | Texas | 75231 | — |
| Doreen Moser, DO | Grapevine | Texas | 76051 | — |
| MacArthur OBGYN | Irving | Texas | 75062 | — |
| Personalized Women's Healthcare | Plano | Texas | 75093 | — |
| Ogden Clinic | Ogden | Utah | 84403 | — |
| Old Farm Obstetrics and Gynecology | Salt Lake City | Utah | 84107 | — |
| Milwaukee ObGyn | Milwaukee | Wisconsin | 53221 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01197547, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 26, 2021 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01197547 live on ClinicalTrials.gov.