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

Primary Purpose

Menorrhagia

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AEGEA Vapor System(TM)
Sponsored by
Aegea Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menorrhagia focused on measuring Endometrial ablation with vapor

Eligibility Criteria

30 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Fertility and Women's Health
  • Clinical Associates of Orlando, LLC
  • Visions Clinical Research
  • Rosemark WomenCares Specialists
  • The Advanced Gynecologic Surgery Institute
  • Basinksi, LLC
  • Minnesota Gynecology & Surgery
  • Mercy Hospital
  • Montefiore Medical Center
  • Carolina Women's Research and Wellness Center/OB-GYN
  • Chattanooga Medical Research, LLC
  • Baylor All Saints
  • Department of Obstetrics and Gynecology
  • Hospital Universitario de la Universidad Autonoma de Nuevo Leon
  • Isala Klinieken

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

vapor endometrial ablation

Arm Description

endometrial ablation using the AEGEA Vapor System

Outcomes

Primary Outcome Measures

Primary Effectiveness Endpoint
Reduction of menstrual blood loss

Secondary Outcome Measures

Secondary Effectiveness Endpoint
Quality of Life

Full Information

First Posted
November 4, 2013
Last Updated
July 8, 2016
Sponsor
Aegea Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01979861
Brief Title
Safety & Effectiveness Study of AEGEA Vapor System to Treat Excessive Uterine Bleeding
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 Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aegea Medical, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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)
Detailed Description
This is a single-arm, multi-center study with three years of follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menorrhagia
Keywords
Endometrial ablation with vapor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
vapor endometrial ablation
Arm Type
Experimental
Arm Description
endometrial ablation using the AEGEA Vapor System
Intervention Type
Device
Intervention Name(s)
AEGEA Vapor System(TM)
Intervention Description
vapor endometrial ablation
Primary Outcome Measure Information:
Title
Primary Effectiveness Endpoint
Description
Reduction of menstrual blood loss
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Secondary Effectiveness Endpoint
Description
Quality of Life
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Levie, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Fertility and Women's Health
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06051
Country
United States
Facility Name
Clinical Associates of Orlando, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Visions Clinical Research
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Rosemark WomenCares Specialists
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
The Advanced Gynecologic Surgery Institute
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60173
Country
United States
Facility Name
Basinksi, LLC
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
Minnesota Gynecology & Surgery
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Mercy Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Carolina Women's Research and Wellness Center/OB-GYN
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Facility Name
Chattanooga Medical Research, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Baylor All Saints
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Department of Obstetrics and Gynecology
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Hospital Universitario de la Universidad Autonoma de Nuevo Leon
City
Monterrey
State/Province
N.l.
Country
Mexico
Facility Name
Isala Klinieken
City
Zwolle
State/Province
Overijissel
ZIP/Postal Code
8025 AB
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33603496
Citation
Leyland N, Harris M. Water Vapor Endometrial Ablation for Heavy Menstrual Bleeding: 36-Month Follow-Up of a Prospective, Multicenter Pivotal Clinical Trial. Int J Womens Health. 2021 Feb 10;13:169-176. doi: 10.2147/IJWH.S279864. eCollection 2021.
Results Reference
derived

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

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