Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: February 21, 2014
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

  • Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Device or procedure related SAEs


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
Device: AEGEA Vapor System(TM)
vapor endometrial ablation

  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
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, 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, Missouri
Mercy Hospital Not yet 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 Magnan    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: Atiya Sherwani    919-251-9223    atiya@cwrwc.com   
Principal Investigator: Andrea S Lukes, MD         
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         
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: February 21, 2014
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 November 25, 2014