Safety & Effectiveness Study of AEGEA Vapor System to Treat Excessive Uterine Bleeding

Status unconfirmed · Phase 3

Conditions studied: Menorrhagia

In brief

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)

Key facts

Study ID

NCT01979861

Run by

Aegea Medical, Inc.

People needed

230

Starts

2014-02-01

Expected to finish

2018-06-01

Last updated by the study team

2016-07-12

Who can join

Age: 30 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Normal endometrial biopsy
• Willing to use reliable contraception
• Not currently taking hormonal medication
• Agree to use sponsor provided catamenial product (sanitary pads/tampons)

You may not qualify if…

• Pregnant
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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