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Registry Study of Genesys HTA for Treatment of Menorrhagia (Genesys HTA)

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ClinicalTrials.gov Identifier: NCT01197547
Recruitment Status : Completed
First Posted : September 9, 2010
Results First Posted : May 17, 2017
Last Update Posted : March 26, 2021
Sponsor:
Information provided by (Responsible Party):
Minerva Surgical, Inc.

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Menorrhagia Device: Genesys HTA Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1014 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Genesys HTA Post Approval Registry A Multi-center, Single-arm, Prospective Registry of the Genesys HTA System for the Treatment of Menorrhagia
Study Start Date : November 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : August 2012
Arms and Interventions
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Arm Intervention/treatment
Genesys HTA
Genesys HTA Endometrial Ablation
 Device: Genesys HTA
Genesys HTA Endometrial Ablation
Other Name: Genesys HTA Endometrial Ablation


Outcome Measures
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Primary Outcome Measures :
  1. Burn Rate [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01197547


Locations
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Sponsors and Collaborators
Minerva Surgical, Inc.
Investigators
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Study Director: Thomas Bowman, M.D. Boston Scientific Corporation
More Information
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Responsible Party: Minerva Surgical, Inc.
ClinicalTrials.gov Identifier: NCT01197547    
Other Study ID Numbers: U8088
First Posted: September 9, 2010    Key Record Dates
Results First Posted: May 17, 2017
Last Update Posted: March 26, 2021
Last Verified: April 2017
Keywords provided by Minerva Surgical, Inc.:
Menorrhagia
Additional relevant MeSH terms:
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Menorrhagia
Uterine Hemorrhage
Uterine Diseases
 Hemorrhage
Pathologic Processes
Menstruation Disturbances