MenorrhagiaPostablationNCT02087228
Evaluation of the Endometrial Cavity After Endometrial Ablation
A study testing Genesys HydroTherm Ablator and radiofrequency energy ablation device in people with Menorrhagia, run by Baylor Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the shape, size and appearance of the inside of the uterus six months following an endometrial ablation procedure. Half of the participants will have their ablation performed with a hydrothermal ablation device and the other half will have their ablation performed with a device… Read more about this study
- Who is it for?
- Ages 18 to 51 years, women only
- Conditions the study is for
- Menorrhagia
- What is being tested?
- Genesys HydroTherm Ablator and radiofrequency energy ablation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 51 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premenopausal women Not pregnant and no future pregnancy desired Willing to randomize the device used for the ablation Willing to undergo diagnostic hysteroscopy with office-based anesthesia 6 months post-ablation
Who cannot join
- Pregnancy or desiring future pregnancy Endometrial hyperplasia Presence of active endometriosis Active pelvic inflammatory disease Previous endometrial ablation procedure
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the shape, size and appearance of the inside of the uterus six months following an endometrial ablation procedure. Half of the participants will have their ablation performed with a hydrothermal ablation device and the other half will have their ablation performed with a device that uses radiofrequency energy.
Read the detailed description
The purpose of this study is to evaluate the shape, size and appearance of the inside of the uterus six months following an endometrial ablation procedure. Half of the participants will have their ablation performed with a hydrothermal ablation device and the other half will have their ablation performed with a device that uses radiofrequency energy. Participants are randomly assigned to one or the other device.
A vaginal ultrasound will be performed before the procedure and again at six months post-procedure.
The inside of the uterus will be visualized via hysteroscopy before the procedure and again at six months post-procedure. Measurements will be taken and the investigator will compare photos taken pre-procedure and six months post-procedure.
- Conditions
- Menorrhagia
- Being tested
- Genesys HydroTherm Ablator, radiofrequency energy ablation device
- Keywords
- Endometrial ablation, 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 HydroTherm AblatorDevice
Heated water is circulated inside the uterus to destroy the lining of the uterus
radiofrequency energy ablation deviceDevice
| Study group | Role | What they receive |
|---|---|---|
| Hydrothermal ablation | Experimental | Uterine ablation performed with a device that circulates heated water inside the uterus Receives: Device: Genesys HydroTherm Ablator |
| radiofrequency energy | Active comparator | ablation performed with a device that uses radiofrequency energy. Receives: Device: radiofrequency energy ablation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visualization of the inside of the uterus
The inside of the uterus will be visualized via hysteroscopy to determine the amount of scarring
Measured: 6 months post-ablation
Secondary outcomes (1)
Measurments of endometrial thickness
Measurements will be taken of the uterine cavity length and endometrial thickness
Measured: 6 months post-ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startSep 2013
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Sponsor and Principle Investigator mutually agreed to terminate study and patients are no longer examined/treated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenorrhagiaStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Delbert A Johns, M.D., Principal investigator, Texas Health Care, Baylor Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087228
- Sponsor's protocol ID
- 013-053
- Other IDs
- BRI-2013-1979
- Acronym
- Postablation
- Status last verified
- Jan 2016
- First submitted
- 10 Mar 2014
- Last updated
- 18 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Endometrial Cavity After Endometrial Ablation
- ClinicalTrials.gov ID
- NCT02087228
- Acronym / sponsor ID
- Postablation / 013-053
- Conditions
- Menorrhagia
- Keywords
- Endometrial ablation, menorrhagia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor and Principle Investigator mutually agreed to terminate study and patients are no longer examined/treated
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 14 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the shape, size and appearance of the inside of the uterus six months following an endometrial ablation procedure. Half of the participants will have their ablation performed with a hydrothermal ablation device and the other half will have their ablation performed with a device that uses radiofrequency energy.
Detailed description
The purpose of this study is to evaluate the shape, size and appearance of the inside of the uterus six months following an endometrial ablation procedure. Half of the participants will have their ablation performed with a hydrothermal ablation device and the other half will have their ablation performed with a device that uses radiofrequency energy. Participants are randomly assigned to one or the other device.
A vaginal ultrasound will be performed before the procedure and again at six months post-procedure.
The inside of the uterus will be visualized via hysteroscopy before the procedure and again at six months post-procedure. Measurements will be taken and the investigator will compare photos taken pre-procedure and six months post-procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrothermal ablation | Experimental | Device: Genesys HydroTherm AblatorUterine ablation performed with a device that circulates heated water inside the uterus |
| radiofrequency energy | Active comparator | Device: radiofrequency energy ablation deviceablation performed with a device that uses radiofrequency energy. |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Premenopausal women Not pregnant and no future pregnancy desired Willing to randomize the device used for the ablation Willing to undergo diagnostic hysteroscopy with office-based anesthesia 6 months post-ablation
Key exclusion criteria (1 listed)
- Pregnancy or desiring future pregnancy Endometrial hyperplasia Presence of active endometriosis Active pelvic inflammatory disease Previous endometrial ablation procedure
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 HydroTherm AblatorHeated water is circulated inside the uterus to destroy the lining of the uterus | Device | Hydrothermal ablation |
| radiofrequency energy ablation device | Device | radiofrequency energy |
Primary outcome
Visualization of the inside of the uterus
Time frame: 6 months post-ablation
The inside of the uterus will be visualized via hysteroscopy to determine the amount of scarring
1 secondary outcome
Measurments of endometrial thickness
Time frame: 6 months post-ablation
Results and safety
The study was stopped early (reason given: Sponsor and Principle Investigator mutually agreed to terminate study and patients are no longer examined/treated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2016.
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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.
Delbert A Johns, M.D. principal investigator
Texas Health Care, Baylor Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genesys HydroTherm Ablator and radiofrequency energy ablation device in people with Menorrhagia, run by Baylor Research Institute at 1 site 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 1 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: stopped early, as of the sponsor's last update on 18 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Sponsor and Principle Investigator mutually agreed to terminate study and patients are no longer examined/treated). Results are not available in the source record.
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?
Visualization of the inside of the uterus (time frame: 6 months post-ablation). 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 18 Jan 2016.