NCT01197547

Registry Study of Genesys HTA for Treatment of Menorrhagia

Genesys HTA Post Approval Registry A Multi-center, Single-arm, Prospective Registry of the Genesys HTA System for the Treatment of Menorrhagia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,014 (actual)
• Sponsor: Minerva Surgical, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	Genesys HTA	Genesys HTA Endometrial Ablation

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-02-01
• Completion: 2012-08-01
• First posted: 2010-09-09
• Last updated: 2021-03-26
• Results posted: 2017-05-17

Locations

19 sites across 1 country: United States