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

Sponsor
Aegea Medical, Inc. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT01979861
Collaborator
(none)
230
Enrollment
15
Locations
1
Arm
51.9
Duration (Months)
15.3
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Device: AEGEA Vapor System(TM)
 Phase 3

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
230 participants
Allocation:
N/A
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
Study Start Date :
Feb 1, 2014
Actual Primary Completion Date :
Jun 1, 2016
Anticipated Study Completion Date :
Jun 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: vapor endometrial ablation

endometrial ablation using the AEGEA Vapor System

Device: AEGEA Vapor System(TM)
vapor endometrial ablation

Outcome Measures

Primary Outcome Measures

  1. Primary Effectiveness Endpoint [12 months]

    Reduction of menstrual blood loss

Secondary Outcome Measures

  1. Secondary Effectiveness Endpoint [12 months]

    Quality of Life

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 50 Years
Sexes 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

Locations

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

Sponsors and Collaborators

  • Aegea Medical, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aegea Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01979861
Other Study ID Numbers:
  • SE-3000
First Posted:
Nov 8, 2013
Last Update Posted:
Jul 12, 2016
Last Verified:
Jul 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Aegea Medical, Inc.
Endometrial ablation with vapor
Additional relevant MeSH terms:
Uterine Hemorrhage
Menorrhagia

Study Results

No Results Posted as of Jul 12, 2016