Safety & Effectiveness Study of AEGEA Vapor System to Treat Excessive Uterine Bleeding
NCT ID: NCT01979861
Last Updated: 2016-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
230 participants
INTERVENTIONAL
2014-02-28
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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vapor endometrial ablation
endometrial ablation using the AEGEA Vapor System
AEGEA Vapor System(TM)
vapor endometrial ablation
Interventions
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AEGEA Vapor System(TM)
vapor endometrial ablation
Eligibility Criteria
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Inclusion Criteria
* 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
* Normal endometrial biopsy
* Willing to use reliable contraception
* Not currently taking hormonal medication
* Agree to use sponsor provided catamenial product (sanitary pads/tampons)
Exclusion Criteria
* Desires future childbearing
* Presence of an IUD
* Previous endometrial ablation procedure
* Evidence of STI
* Evidence of PID
* 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
30 Years
50 Years
FEMALE
No
Sponsors
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Aegea Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Levie, MD
Role: PRINCIPAL_INVESTIGATOR
Montefiore Medical Center
Locations
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Center for Fertility and Women's Health
New Britain, Connecticut, United States
Clinical Associates of Orlando, LLC
Orlando, Florida, United States
Visions Clinical Research
Wellington, Florida, United States
Rosemark WomenCares Specialists
Idaho Falls, Idaho, United States
The Advanced Gynecologic Surgery Institute
Naperville, Illinois, United States
Basinksi, LLC
Newburgh, Indiana, United States
Minnesota Gynecology & Surgery
Edina, Minnesota, United States
Mercy Hospital
St Louis, Missouri, United States
Montefiore Medical Center
The Bronx, New York, United States
Carolina Women's Research and Wellness Center/OB-GYN
Durham, North Carolina, United States
Chattanooga Medical Research, LLC
Chattanooga, Tennessee, United States
Baylor All Saints
Fort Worth, Texas, United States
Department of Obstetrics and Gynecology
Hamilton, Ontario, Canada
Hospital Universitario de la Universidad Autonoma de Nuevo Leon
Monterrey, N.l., Mexico
Isala Klinieken
Zwolle, Overijissel, Netherlands
Countries
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References
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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.
Other Identifiers
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SE-3000
Identifier Type: -
Identifier Source: org_study_id
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