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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Aegea Medical, Inc. Identifier:
First received: November 4, 2013
Last updated: May 2, 2015
Last verified: May 2015
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)

Condition Intervention Phase
Device: AEGEA Vapor System(TM)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Aegea Medical, Inc.:

Primary Outcome Measures:
  • Primary Effectiveness Endpoint [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Reduction of menstrual blood loss

Secondary Outcome Measures:
  • Secondary Effectiveness Endpoint [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Quality of Life

Estimated Enrollment: 230
Study Start Date: February 2014
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vapor endometrial ablation
endometrial ablation using the AEGEA Vapor System
Device: AEGEA Vapor System(TM)
vapor endometrial ablation

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

Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01979861

United States, Connecticut
Center for Fertility and Women's Health
New Britain, Connecticut, United States, 06051
United States, Florida
Clinical Associates of Orlando, LLC
Orlando, Florida, United States, 32801
Visions Clinical Research
Wellington, Florida, United States, 33414
United States, Idaho
Rosemark WomenCares Specialists
Idaho Falls, Idaho, United States, 83404
United States, Illinois
The Advanced Gynecologic Surgery Institute
Naperville, Illinois, United States, 60173
United States, Indiana
Basinksi, LLC
Newburgh, Indiana, United States, 47630
United States, Minnesota
Minnesota Gynecology & Surgery
Edina, Minnesota, United States, 55435
United States, Missouri
Mercy Hospital
St. Louis, Missouri, United States, 63141
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
United States, North Carolina
Carolina Women's Research and Wellness Center/OB-GYN
Durham, North Carolina, United States, 27713
United States, Tennessee
Chattanooga Medical Research, LLC
Chattanooga, Tennessee, United States, 37404
United States, Texas
Baylor All Saints
Fort Worth, Texas, United States, 76104
Canada, Ontario
Department of Obstetrics and Gynecology
Hamilton, Ontario, Canada, L8N 3Z5
Hospital Universitario de la Universidad Autonoma de Nuevo Leon
Monterrey, N.l., Mexico
Isala Klinieken
Zwolle, Overijissel, Netherlands, 8025 AB
Sponsors and Collaborators
Aegea Medical, Inc.
Principal Investigator: Mark Levie, MD Montefiore Medical Center
  More Information

No publications provided

Responsible Party: Aegea Medical, Inc. Identifier: NCT01979861     History of Changes
Other Study ID Numbers: SE-3000
Study First Received: November 4, 2013
Last Updated: May 2, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Aegea Medical, Inc.:
Endometrial ablation with vapor

Additional relevant MeSH terms:
Uterine Hemorrhage
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes
Uterine Diseases processed this record on November 25, 2015