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NCT01197547 · ClinicalTrials.gov registry record · NA
Registry Study of Genesys HTA for Treatment of Menorrhagia
A NA study, sponsored by Minerva Surgical.
- Completed
- Registry status
- NA
- Development phase
- 1,014
- Enrollment target
NCT01197547 is a NA study that has completed, run by Minerva Surgical. The registered enrollment target is 1,014 participants.
The verdict
NCT01197547, a NA study, has completed, sponsored by Minerva Surgical.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,014 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Genesys HTA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,014 participants |
| Start Date | 2010-11 |
| Est. Completion | 2012-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01197547
The ClinicalTrials.gov registry entry for NCT01197547 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1,014 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Minerva Surgical, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Genesys HTA is the first listed.
NCT01197547 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01197547 about?
NCT01197547 is a clinical study titled "Registry Study of Genesys HTA for Treatment of Menorrhagia". 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 ch...
What is the current status of trial NCT01197547?
This trial is currently completed. It is a NA study. The enrollment target is 1,014 participants. The study started on 2010-11. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01197547?
The interventions under investigation include: Genesys HTA (DEVICE).
Who is sponsoring clinical trial NCT01197547?
This trial is sponsored by Minerva Surgical, which has 3 total clinical trials registered on ClinicalTrials.gov.
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