Registry Study of Genesys HTA for Treatment of Menorrhagia

Completed · Not applicable

Conditions studied: Menorrhagia

In brief

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.

Key facts

Study ID

NCT01197547

Run by

Minerva Surgical, Inc.

People needed

1014

Starts

2010-11-01

Expected to finish

2012-08-01

Last updated by the study team

2021-03-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Subject must meet the approved indication for use to be considered for this registry.

You may not qualify if…

• All subjects contraindicated for the treatment of the Genesys HTA System per the Directions for Use will be excluded:
• The subject is pregnant or wants to be pregnant in the future
• The subject has known or suspected endometrial carcinoma or premalignant change of the endometrium, such as adenomatous hyperplasia
• The subject has active pelvic inflammatory disease or pyosalpinx
• The subject has hydrosalpinx
• The subject in whom a tight cervical seal cannot be established and maintained around the procedure sheath
• 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
• The subject has an intrauterine device in place
• The subject has an active genital or urinary tract infection (e.g. cervicitis, endometritis, vaginitis, cystitis, etc.) at the time of treatment

Where it is running

• Sharp Mary Birch — San Diego, California, United States
• Christiana Hospital — Newark, Delaware, United States
• Shelnutt Obstetrics and Gynecology — Athens, Georgia, United States
• Health South Surgecenter of Louisville — Louisville, Kentucky, United States
• Wayne State University Physician Group — Southfield, Michigan, United States
• Seven Hills OB GYN Associates — Cincinnati, Ohio, United States
• Complete Healthcare for Women — Columbus, Ohio, United States
• Associates in Women's Healthcare — Philadelphia, Pennsylvania, United States
• Schuykill Medical Center South — Pottsville, Pennsylvania, United States
• Chattanooga Medical Research — Chattanooga, Tennessee, United States
• State of Franklin Healthcare Associates — Johnson City, Tennessee, United States
• Associates in Obstetrics and Gynecology — Bedford, Texas, United States
• Central Womens Care PA — Dallas, Texas, United States
• Doreen Moser, DO — Grapevine, Texas, United States
• MacArthur OBGYN — Irving, Texas, United States
• Personalized Women's Healthcare — Plano, Texas, United States
• Ogden Clinic — Ogden, Utah, United States
• Old Farm Obstetrics and Gynecology — Salt Lake City, Utah, United States
• Milwaukee ObGyn — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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