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

Menorrhagia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01979861
• Other study ID #: SE-3000
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 4, 2013
• Last updated: July 8, 2016
• Start date: February 2014
• Est. completion date: June 2018

Study information

• Verified date: July 2016
• Source: Aegea Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 230
• Est. completion date: June 2018
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menorrhagia
• Uterine Hemorrhage

Intervention

Device:
• AEGEA Vapor System(TM)
vapor endometrial ablation

Locations

Country	Name	City	State
Canada	Department of Obstetrics and Gynecology	Hamilton	Ontario
Mexico	Hospital Universitario de la Universidad Autonoma de Nuevo Leon	Monterrey	N.l.
Netherlands	Isala Klinieken	Zwolle	Overijissel
United States	Montefiore Medical Center	Bronx	New York
United States	Chattanooga Medical Research, LLC	Chattanooga	Tennessee
United States	Carolina Women's Research and Wellness Center/OB-GYN	Durham	North Carolina
United States	Minnesota Gynecology & Surgery	Edina	Minnesota
United States	Baylor All Saints	Fort Worth	Texas
United States	Rosemark WomenCares Specialists	Idaho Falls	Idaho
United States	The Advanced Gynecologic Surgery Institute	Naperville	Illinois
United States	Center for Fertility and Women's Health	New Britain	Connecticut
United States	Basinksi, LLC	Newburgh	Indiana
United States	Clinical Associates of Orlando, LLC	Orlando	Florida
United States	Mercy Hospital	St. Louis	Missouri
United States	Visions Clinical Research	Wellington	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Aegea Medical, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Mexico,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Effectiveness Endpoint	Reduction of menstrual blood loss	12 months	No
Secondary	Secondary Effectiveness Endpoint	Quality of Life	12 months	No