MenorrhagiaPhase 3NCT01979861
Safety & Effectiveness Study of AEGEA Vapor System to Treat Excessive Uterine Bleeding
A Phase 3 study testing AEGEA Vapor System(TM) in people with Menorrhagia, run by Aegea Medical, Inc. at 15 sites in 4 countries.
Trial summary
The purpose of this study is to determine if the AEGEA Vapor System for endometrial ablation is safe and effective for reducing menstrual blood loss in women with excessive uterine bleeding (menorrhagia) Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Menorrhagia
- What is being tested?
- AEGEA Vapor System(TM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 15 sitesin 4 countries
- Study dates
- Feb 2014to Jun 2018
- Phase
- Phase 3
- 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 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female subject from (and including) age 30 to 50 years
- Self-reported history of heavy menstrual bleeding in at least 3 of the last 6 months
- Predictable cyclic menstrual cycles over past 6 months
- Excessive uterine bleeding
- Premenopausal at enrollment
- Normal PAP
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- Normal endometrial biopsy
- Willing to use reliable contraception
- Not currently taking hormonal medication
- Agree to use sponsor provided catamenial product (sanitary pads/tampons)
Who cannot join
- Pregnant
- Desires future childbearing
- Presence of an IUD
- Previous endometrial ablation procedure
- Evidence of STI
- Evidence of PID
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- Active infection of genitals, vagina, cervix, uterus or urinary tract
- Active endometritis
- Active bacteremia, sepsis or other active systemic infection
- Gynecologic malignancy
- Endometrial hyperplasia
- Known clotting defects or bleeding disorders
- On anticoagulant therapy
- Hemoglobin <8gm/dl
- Prior uterine surgery
- Currently on medication that could thin myometrial muscle
- Severe dysmenorrhea, secondary to adenomyosis
- Abnormal uterine cavity
- Hydrosalpinx
- Uterine length <6cm or >12cm
- Currently in other clinical trial
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
United States12 sites
Chattanooga Medical Research, LLC
Chattanooga, Tennessee, 37404
Carolina Women's Research and Wellness Center/OB-GYN
Durham, North Carolina, 27713
Minnesota Gynecology & Surgery
Edina, Minnesota, 55435
Baylor All Saints
Fort Worth, Texas, 76104
Rosemark WomenCares Specialists
Idaho Falls, Idaho, 83404
The Advanced Gynecologic Surgery Institute
Naperville, Illinois, 60173
Center for Fertility and Women's Health
New Britain, Connecticut, 06051
Basinksi, LLC
Newburgh, Indiana, 47630
Clinical Associates of Orlando, LLC
Orlando, Florida, 32801
Mercy Hospital
St Louis, Missouri, 63141
Montefiore Medical Center
The Bronx, New York, 10467
Visions Clinical Research
Wellington, Florida, 33414
Canada1 site
Department of Obstetrics and Gynecology
Hamilton, Ontario, L8N 3Z5
Mexico1 site
Hospital Universitario de la Universidad Autonoma de Nuevo Leon
Monterrey, N.l.
About this study
Official title: A Prospective, Multicenter, Clinical Trial to Evaluate the Safety and Effectiveness of the AEGEA Vapor System for the Treatment of Excessive Uterine Bleeding
The purpose of this study is to determine if the AEGEA Vapor System for endometrial ablation is safe and effective for reducing menstrual blood loss in women with excessive uterine bleeding (menorrhagia)
Read the detailed description
This is a single-arm, multi-center study with three years of follow-up.
- Conditions
- Menorrhagia
- Being tested
- AEGEA Vapor System(TM)
- Keywords
- Endometrial ablation with vapor
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AEGEA Vapor System(TM)Device
vapor endometrial ablation
| Study group | Role | What they receive |
|---|---|---|
| vapor endometrial ablation | Experimental | endometrial ablation using the AEGEA Vapor System Receives: Device: AEGEA Vapor System(TM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint
Reduction of menstrual blood loss
Measured: 12 months
Secondary outcomes (1)
Secondary Effectiveness Endpoint
Quality of Life
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startFeb 2014
- Primary completionJun 2016
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aegea Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Levie, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979861
- Sponsor's protocol ID
- SE-3000
- Status last verified
- Jul 2016
- First submitted
- 4 Nov 2013
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Leyland N, Harris M. Water Vapor Endometrial Ablation for Heavy Menstrual Bleeding: 36-Month Follow-Up of a Prospective, Multicenter Pivotal Clinical Trial. Int J Womens Health. 2021 Feb 10;13:169-176. doi: 10.2147/IJWH.S279864. eCollection 2021.
PubMed 33603496
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Clinical Trial to Evaluate the Safety and Effectiveness of the AEGEA Vapor System for the Treatment of Excessive Uterine Bleeding
- ClinicalTrials.gov ID
- NCT01979861
- Acronym / sponsor ID
- SE-3000
- Conditions
- Menorrhagia
- Keywords
- Endometrial ablation with vapor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Aegea Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2018 (estimated)
- First posted
- 8 Nov 2013 (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 determine if the AEGEA Vapor System for endometrial ablation is safe and effective for reducing menstrual blood loss in women with excessive uterine bleeding (menorrhagia)
Detailed description
This is a single-arm, multi-center study with three years of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vapor endometrial ablation | Experimental | Device: AEGEA Vapor System(TM)endometrial ablation using the AEGEA Vapor System |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Female subject from (and including) age 30 to 50 years
- Self-reported history of heavy menstrual bleeding in at least 3 of the last 6 months
- Predictable cyclic menstrual cycles over past 6 months
- Excessive uterine bleeding
- Premenopausal at enrollment
Key exclusion criteria (21 listed)
- Pregnant
- Desires future childbearing
- Presence of an IUD
- Previous endometrial ablation procedure
- Evidence of STI
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 |
|---|---|---|
| AEGEA Vapor System(TM)vapor endometrial ablation | Device | vapor endometrial ablation |
Primary outcome
Primary Effectiveness Endpoint
Time frame: 12 months
Reduction of menstrual blood loss
1 secondary outcome
Secondary Effectiveness Endpoint
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
- Derived from this study: PubMed 33603496Leyland N, Harris M. Water Vapor Endometrial Ablation for Heavy Menstrual Bleeding: 36-Month Follow-Up of a Prospective, Multicenter Pivotal Clinical Trial. Int J Womens Health. 2021 Feb 10;13:169-176. doi: 10.2147/IJWH.S279864. eCollection 2021.
- Individual participant dataSharing planned: No
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A Clinical Study of the Aqua Therapeutics Thermal Therapy Vapor Ablation System in Premenopausal Women With Abnormal Uterine Bleeding
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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.
Mark Levie, MD principal investigator
Montefiore Medical Center
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AEGEA Vapor System(TM) in people with Menorrhagia, run by Aegea Medical, Inc. at 15 sites in 4 countries.
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 10 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Canada, Mexico, Netherlands. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Primary Effectiveness Endpoint (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01979861, which also lists 1 linked publication.
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 12 Jul 2016.