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)
This is a single-arm, multi-center study with three years of follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
230
vapor endometrial ablation
Center for Fertility and Women's Health
New Britain, Connecticut, United States
Clinical Associates of Orlando, LLC
Orlando, Florida, United States
Primary Effectiveness Endpoint
Reduction of menstrual blood loss
Time frame: 12 months
Secondary Effectiveness Endpoint
Quality of Life
Time frame: 12 months
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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
...and 5 more locations