Overview

This trial is active, not recruiting.

Condition menorrhagia
Treatment aegea vapor system(tm)
Phase phase 3
Sponsor Aegea Medical, Inc.
Start date February 2014
End date June 2016
Trial size 230 participants
Trial identifier NCT01979861, SE-3000

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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
endometrial ablation using the AEGEA Vapor System
aegea vapor system(tm)
vapor endometrial ablation

Primary Outcomes

Measure
Primary Effectiveness Endpoint
time frame: 12 months

Secondary Outcomes

Measure
Secondary Effectiveness Endpoint
time frame: 12 months

Eligibility Criteria

Female participants from 30 years up to 50 years old.

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

Additional Information

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
Principal investigator Mark Levie, MD
Description This is a single-arm, multi-center study with three years of follow-up.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Aegea Medical, Inc..