Clinical Trial: Registry Study of Genesys HTA for Treatment of Menorrhagia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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:

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.


Detailed Summary:
Sponsor: Boston Scientific Corporation

Current Primary Outcome: Burn Rate [ Time Frame: Day 1 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Technical Malfunctions [ Time Frame: Day 1 ]
    A secondary endpoint of the Genesys HTA Post Approval Study is to assess technical complaints (i.e. disposable and hardware issues). Technical complaints are issues related to system components encountered during the procedure such as error messages, problems with the connection, power, early incomplete procedure terminations, or display/user interface, or damage to the unit.
  • Serious Adverse Device Effect (SADE) [ Time Frame: Day 1 ]
    A secondary endpoint of the Genesys HTA Post Approval Study is to assess Serious Adverse Device Effects. Per the approved protocol, an SADE is an adverse device effect resulting in any of the consequences characteristic of a serious adverse event, or that might have led to any of these consequences if suitable action had not been taken or intervention had not been made, or if circumstances had been less opportune.


Original Secondary Outcome: Technical malfunctions and SADEs [ Time Frame: Day 1 ]

Information By: Boston Scientific Corporation

Dates:
Date Received: September 1, 2010
Date Started: November 2010
Date Completion:
Last Updated: April 7, 2017
Last Verified: April 2017