NCT01979861

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)

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
230

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2014

Typical duration for phase_3

Geographic Reach
4 countries

15 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 12, 2016

Status Verified

July 1, 2016

Enrollment Period

2.3 years

First QC Date

November 4, 2013

Last Update Submit

July 8, 2016

Conditions

Menorrhagia

Keywords

Endometrial ablation with vapor

Outcome Measures

Primary Outcomes (1)

  • Primary Effectiveness Endpoint

    Reduction of menstrual blood loss

    12 months

Secondary Outcomes (1)

  • Secondary Effectiveness Endpoint

    12 months

Study Arms (1)

vapor endometrial ablation

EXPERIMENTAL

endometrial ablation using the AEGEA Vapor System

Device: AEGEA Vapor System(TM)

Interventions

AEGEA Vapor System(TM)DEVICE

vapor endometrial ablation

vapor endometrial ablation

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Center for Fertility and Women's Health

New Britain, Connecticut, 06051, United States

Location

Clinical Associates of Orlando, LLC

Orlando, Florida, 32801, United States

Location

Visions Clinical Research

Wellington, Florida, 33414, United States

Location

Rosemark WomenCares Specialists

Idaho Falls, Idaho, 83404, United States

Location

The Advanced Gynecologic Surgery Institute

Naperville, Illinois, 60173, United States

Location

Basinksi, LLC

Newburgh, Indiana, 47630, United States

Location

Minnesota Gynecology & Surgery

Edina, Minnesota, 55435, United States

Location

Mercy Hospital

St Louis, Missouri, 63141, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Carolina Women's Research and Wellness Center/OB-GYN

Durham, North Carolina, 27713, United States

Location

Chattanooga Medical Research, LLC

Chattanooga, Tennessee, 37404, United States

Location

Baylor All Saints

Fort Worth, Texas, 76104, United States

Location

Department of Obstetrics and Gynecology

Hamilton, Ontario, L8N 3Z5, Canada

Location

Hospital Universitario de la Universidad Autonoma de Nuevo Leon

Monterrey, N.l., Mexico

Location

Isala Klinieken

Zwolle, Overijissel, 8025 AB, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 33603496DERIVED

MeSH Terms

Conditions

Menorrhagia

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation Disturbances

Study Officials

  • Mark Levie, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2013

First Posted

November 8, 2013

Study Start

February 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2018

Last Updated

July 12, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

US(12)CA(1)ME(1)NL(1)