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Completed

NCT Number: NCT01197547

Registry Study of Genesys HTA for Treatment of Menorrhagia

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.

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Key information

Conditions

Menorrhagia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sharp Mary Birch, San Diego, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

Treatment and study plan

Genesys HTA

Device

Genesys HTA Endometrial Ablation

Other names: Genesys HTA Endometrial Ablation

Primary outcomes

  1. Burn Rate

    Time frame: Day 1

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Minerva Surgical, Inc.

Industry

Registry information

Official study title

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

Acronym: Genesys HTA

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 9, 2010
Registry last updated
Mar 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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