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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Aegea Medical, Inc.
Sponsor:
Information provided by (Responsible Party):
Aegea Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01979861
First received: November 4, 2013
Last updated: January 12, 2015
Last verified: February 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    Reduction of menstrual blood loss


Secondary Outcome Measures:
  • Secondary Effectiveness Endpoint [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Quality of Life


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

Ages Eligible for Study:   30 Years to 50 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01979861

Contacts
Contact: Connie A Rey (650)218-7225 crey@aegeamedical.com
Contact: Ekta Wilcox (248)624-7702 ektawilcox@yahoo.com

Locations
United States, Connecticut
Center for Fertility and Women's Health Recruiting
New Britain, Connecticut, United States, 06051
Contact: Heidi Lytton    860-224-5900    heidi.lytton@hhchealth.org   
Principal Investigator: Anthony Luciano, MD         
United States, Florida
Clinical Associates of Orlando, LLC Recruiting
Orlando, Florida, United States, 32801
Contact: Shawna Martin    407-269-0322    smartin@clinicalassociatesorlando.com   
Contact: Carlton Martin       cmartin@clinicalassociatesorlando.com   
Principal Investigator: Christopher A Walker, MD         
Visions Clinical Research Recruiting
Wellington, Florida, United States, 33414
Contact: Stephanie Fenwick    561-964-7880    Sfenwick@atlanticclinicalresearch.com   
Principal Investigator: Seth J Herbst, MD, PhD         
United States, Idaho
Rosemark WomenCares Specialists Recruiting
Idaho Falls, Idaho, United States, 83404
Contact: DeAnn Walker    208-557-2991    dwalker@rosemark.net   
Contact: Lisa Boozer    208-557-2981    lboozer@rosemark.net   
Principal Investigator: Jeffrey B Baker, MD, CPI         
United States, Illinois
The Advanced Gynecologic Surgery Institute Recruiting
Naperville, Illinois, United States, 60173
Contact: Mary Johnston    630-364-1119    mjohnston@charlesmillermd.org   
Principal Investigator: Charles E Miller, MD         
United States, Indiana
Basinksi, LLC Recruiting
Newburgh, Indiana, United States, 47630
Contact: Valerie Carter    812-853-3500    valerie@drbasinski.com   
Principal Investigator: Cindy M Basinski, MD         
United States, Minnesota
Minnesota Gynecology & Surgery Recruiting
Edina, Minnesota, United States, 55435
Contact: Jennifer Presthus    612-382-4461    presthus@hotmail.com   
Principal Investigator: James B Presthus, MD,         
United States, Missouri
Mercy Hospital Recruiting
St. Louis, Missouri, United States, 63141
Contact: Teresa J Beaudoin, RN, BSN    314-583-7473    tjbranca1@sbcglobal.net   
Principal Investigator: David Levine, MD         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Maureen Magnani    718-405-8396    mmagnani@montefiore.org   
Principal Investigator: Mark D Levie, MD         
United States, North Carolina
Carolina Women's Research and Wellness Center/OB-GYN Recruiting
Durham, North Carolina, United States, 27713
Contact: Moya Burkett    919-251-9223    Moya@cwrwc.com   
Principal Investigator: Andrea S Lukes, MD         
United States, Tennessee
Chattanooga Medical Research, LLC Recruiting
Chattanooga, Tennessee, United States, 37404
Contact: Jeana Ricks    423-648-7794    jricks@chattmedresearch.com   
United States, Texas
Baylor All Saints Recruiting
Fort Worth, Texas, United States, 76104
Contact: Theresa Cheney    817-922-2579    theresa.cheyne@baylorhealth.edu   
Principal Investigator: Delbert A Johns, MD         
Canada, Ontario
Department of Obstetrics and Gynecology Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Pam Singh    905-525-9140    singhp@mcmaster.ca   
Principal Investigator: Nicholas A Leyland, MD         
Mexico
Hospital Universitario de la Universidad Autonoma de Nuevo Leon Recruiting
Monterrey, N.l., Mexico
Contact: Lorena Castillo Sanez    83-72-44-44    angeladrian03@hotmail.com   
Principal Investigator: Jose Gerardo Garza Leal, MD         
Netherlands
Isala Klinieken Recruiting
Zwolle, Overijissel, Netherlands, 8025 AB
Contact: Nitolanda van Rijn    31(0)38 424 8219    n.c.w.van.rijn@isala.nl   
Principal Investigator: Hugo van Eijndhoven, MD         
Sponsors and Collaborators
Aegea Medical, Inc.
Investigators
Principal Investigator: Mark Levie, MD Montefiore Medical Center
  More Information

No publications provided

Responsible Party: Aegea Medical, Inc.
ClinicalTrials.gov Identifier: NCT01979861     History of Changes
Other Study ID Numbers: SE-3000
Study First Received: November 4, 2013
Last Updated: January 12, 2015
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 30, 2015