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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: Completed NA study, sponsored by Minerva Surgical.

NCT01197547 is a NA study that has completed, run by Minerva Surgical. The registered enrollment target is 1,014 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 1,014 participants
Start Date 2010-11
Est. Completion 2012-08
Phase NA
Minerva Surgical

3 total trials

What the finished NCT01197547 record still lists

NCT01197547 is an interventional study that assigns participants to a tested intervention. Its 1,014 participants enrollment target places it among the larger protocols in the corpus, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (28% lower).

The record links to 0 conditions, and to 1 intervention - of which Genesys HTA is the first listed.

NCT01197547 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01197547's enrollment target sits among peer trials

1,014 106th of 2000 higher than 1,895 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01197547, the US trial registry maintained by the National Library of Medicine. NCT01197547 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.