Registry Study of Genesys HTA for Treatment of Menorrhagia

N/ACompletedNCT01197547

Minerva Surgical, Inc.1,014 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

1,014

Conditions

Menorrhagia

Interventions

Genesys HTADEVICE

Genesys HTA Endometrial Ablation

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject must meet the approved indication for use to be considered for this registry. Exclusion Criteria: * All subjects contraindicated for the treatment of the Genesys HTA System per the Directions for Use will be excluded: 1. The subject is pregnant or wants to be pregnant in the future 2. The subject has known or suspected endometrial carcinoma or premalignant change of the endometrium, such as adenomatous hyperplasia 3. The subject has active pelvic inflammatory disease or pyosalpinx 4. The subject has hydrosalpinx 5. The subject in whom a tight cervical seal cannot be established and maintained around the procedure sheath 6. The subject has an anatomical condition (e.g. history of previous classical cesarean section or transmural myomectomy) or pathologic condition (e.g. long term medical therapy) that could lead to weakening of the myometrium 7. The subject has an intrauterine device in place 8. The subject has an active genital or urinary tract infection (e.g. cervicitis, endometritis, vaginitis, cystitis, etc.) at the time of treatment

Locations (19)

Sharp Mary Birch

San Diego, California, United States

Christiana Hospital

Newark, Delaware, United States

Outcomes

Primary Outcomes

Burn Rate

Time frame: Day 1

Secondary Outcomes

Technical Malfunctions

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.

Time frame: Day 1

Serious Adverse Device Effect (SADE)

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.

Time frame: Day 1

Data from ClinicalTrials.gov

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