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

Phase 3

• Conditions: Menorrhagia
• Interventions: Device: AEGEA Vapor System(TM)

• Registration Number: NCT01979861
• Lead Sponsor: Aegea Medical, Inc.

Brief 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)

Detailed Description

This is a single-arm, multi-center study with three years of follow-up.

Study Timeline

• Study First Submitted: 2013-11-04
• Study First Submitted QC: 2013-11-07
• Study First Posted: 2013-11-08
• Study Start: 2014-02
• Primary Completion: 2016-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-08
• Last Update Posted: 2016-07-12
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 230

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
vapor endometrial ablation	AEGEA Vapor System(TM)	endometrial ablation using the AEGEA Vapor System

Primary Outcome Measures

Name	Time	Method
Primary Effectiveness Endpoint	12 months	Reduction of menstrual blood loss

Secondary Outcome Measures

Name	Time	Method
Secondary Effectiveness Endpoint	12 months	Quality of Life

Trial Locations

Locations (15)

Center for Fertility and Women's Health; 🇺🇸 New Britain, Connecticut, United States

Clinical Associates of Orlando, LLC; 🇺🇸 Orlando, 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

Carolina Women's Research and Wellness Center/OB-GYN; 🇺🇸 Durham, North Carolina, United States

Baylor All Saints; 🇺🇸 Fort Worth, Texas, United States

Department of Obstetrics and Gynecology; 🇨🇦 Hamilton, Ontario, Canada

Isala Klinieken; 🇳🇱 Zwolle, Overijissel, Netherlands

Hospital Universitario de la Universidad Autonoma de Nuevo Leon; 🇲🇽 Monterrey, N.l., Mexico

Chattanooga Medical Research, LLC; 🇺🇸 Chattanooga, Tennessee, United States

Visions Clinical Research; 🇺🇸 Wellington, Florida, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States