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

July 8, 2016 updated by: Aegea Medical, Inc.

A Prospective, Multicenter, Clinical Trial to Evaluate the Safety and Effectiveness of the AEGEA Vapor System for the Treatment of Excessive Uterine Bleeding

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

230

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vapor endometrial ablation
endometrial ablation using the AEGEA Vapor System
Device: AEGEA Vapor System(TM)
vapor endometrial ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Effectiveness Endpoint
Time Frame: 12 months
Reduction of menstrual blood loss
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Effectiveness Endpoint
Time Frame: 12 months
Quality of Life
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aegea Medical, Inc.

Investigators

  • Principal Investigator: Mark Levie, MD, Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

November 4, 2013

First Submitted That Met QC Criteria

November 7, 2013

First Posted (Estimate)

November 8, 2013

Study Record Updates

Last Update Posted (Estimate)

July 12, 2016

Last Update Submitted That Met QC Criteria

July 8, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SE-3000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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