MenorrhagiaGenesys HTANCT01197547
Registry Study of Genesys HTA for Treatment of Menorrhagia
A study testing Genesys HTA in people with Menorrhagia, run by Minerva Surgical, Inc. at 19 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Menorrhagia
- What is being tested?
- Genesys HTA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,014 participants
- Where
- 19 sitesUnited States
- Study dates
- Nov 2010to Aug 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must meet the approved indication for use to be considered for this registry.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Shelnutt Obstetrics and Gynecology
Athens, Georgia, 30606
Associates in Obstetrics and Gynecology
Bedford, Texas, 76021
Chattanooga Medical Research
Chattanooga, Tennessee, 37404
Seven Hills OB GYN Associates
Cincinnati, Ohio, 45201
Complete Healthcare for Women
Columbus, Ohio, 43213
Central Womens Care PA
Dallas, Texas, 75231
Doreen Moser, DO
Grapevine, Texas, 76051
MacArthur OBGYN
Irving, Texas, 75062
State of Franklin Healthcare Associates
Johnson City, Tennessee, 37604
Health South Surgecenter of Louisville
Louisville, Kentucky, 40207
Milwaukee ObGyn
Milwaukee, Wisconsin, 53221
Christiana Hospital
Newark, Delaware, 19718
Ogden Clinic
Ogden, Utah, 84403
Associates in Women's Healthcare
Philadelphia, Pennsylvania, 19115
Personalized Women's Healthcare
Plano, Texas, 75093
Schuykill Medical Center South
Pottsville, Pennsylvania, 17901
Old Farm Obstetrics and Gynecology
Salt Lake City, Utah, 84107
Sharp Mary Birch
San Diego, California, 92123
Wayne State University Physician Group
Southfield, Michigan, 48034
About this study
Official title: Genesys HTA Post Approval Registry A Multi-center, Single-arm, Prospective Registry of the Genesys HTA System for the 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.
- Conditions
- Menorrhagia
- Being tested
- Genesys HTA
- Keywords
- Menorrhagia
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genesys HTADevice
Also called Genesys HTA Endometrial Ablation
Genesys HTA Endometrial Ablation
| Study group | Role | What they receive |
|---|---|---|
| Genesys HTA | Other | Genesys HTA Endometrial Ablation Receives: Device: Genesys HTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burn Rate
Measured: Day 1
Secondary outcomes (2)
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.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startNov 2010
- Primary completionFeb 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MenorrhagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,014 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minerva Surgical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Bowman, M.D., Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197547
- Sponsor's protocol ID
- U8088
- Acronym
- Genesys HTA
- Status last verified
- Apr 2017
- First submitted
- 1 Sep 2010
- Last updated
- 26 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genesys HTA Post Approval Registry A Multi-center, Single-arm, Prospective Registry of the Genesys HTA System for the Treatment of Menorrhagia
- ClinicalTrials.gov ID
- NCT01197547
- Acronym / sponsor ID
- Genesys HTA / U8088
- Conditions
- Menorrhagia
- Keywords
- Menorrhagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,014 participants (actual)
- Lead sponsor
- Minerva Surgical, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 9 Sep 2010 (estimated)
- Results
- Posted 17 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genesys HTA | Other | Device: Genesys HTAGenesys HTA Endometrial Ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject must meet the approved indication for use to be considered for this registry.
Key exclusion criteria (9 listed)
- All subjects contraindicated for the treatment of the Genesys HTA System per the Directions for Use will be excluded:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genesys HTAAlso: Genesys HTA Endometrial AblationGenesys HTA Endometrial Ablation | Device | Genesys HTA |
Primary outcome
Burn Rate
Time frame: Day 1
2 secondary outcomes
Technical Malfunctions
Time frame: Day 1
Serious Adverse Device Effect (SADE)
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Bowman, M.D. study director
Boston Scientific Corporation
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genesys HTA in people with Menorrhagia, run by Minerva Surgical, Inc. at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Burn Rate (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2021.