Registry Study of Genesys HTA for Treatment of Menorrhagia

Minerva Surgical

Status: Completed

Conditions: Menorrhagia

Treatments: Device: Genesys HTA

Study type: Interventional

Funder types: Industry

Identifiers

NCT01197547

U8088

Details and patient eligibility

About

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.

Enrollment: 1,014 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,014 participants in 1 patient group

Genesys HTA

Other group

Description:

Genesys HTA Endometrial Ablation

Treatment:

Device: Genesys HTA