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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01979861
First Posted: November 8, 2013
Last Update Posted: July 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Aegea Medical, Inc.
  Purpose
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
Menorrhagia Device: AEGEA Vapor System(TM) Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 ]
    Reduction of menstrual blood loss


Secondary Outcome Measures:
  • Secondary Effectiveness Endpoint [ Time Frame: 12 months ]
    Quality of Life


Estimated Enrollment: 230
Study Start Date: February 2014
Estimated Study Completion Date: June 2018
Primary Completion Date: June 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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01979861


Locations
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
Mexico
Hospital Universitario de la Universidad Autonoma de Nuevo Leon
Monterrey, N.l., Mexico
Netherlands
Isala Klinieken
Zwolle, Overijissel, Netherlands, 8025 AB
Sponsors and Collaborators
Aegea Medical, Inc.
Investigators
Principal Investigator: Mark Levie, MD Montefiore Medical Center
  More Information

Responsible Party: Aegea Medical, Inc.
ClinicalTrials.gov Identifier: NCT01979861     History of Changes
Other Study ID Numbers: SE-3000
First Submitted: November 4, 2013
First Posted: November 8, 2013
Last Update Posted: July 12, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Menorrhagia
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes
Hemorrhage