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Registry Study of Genesys HTA for Treatment of Menorrhagia

NCT01197547 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1014

Last updated 2021-03-26

Study results available
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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.

Conditions

  • Menorrhagia

Interventions

DEVICE

Genesys HTA

Genesys HTA Endometrial Ablation

Sponsors & Collaborators

  • Minerva Surgical, Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas Bowman, M.D. · Boston Scientific Corporation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-02-29
Completion
2012-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01197547 on ClinicalTrials.gov