NCT01979861UnknownPhase 3
A Prospective, Multicenter, Clinical Trial to Evaluate the Safety and Effectiveness of the AEGEA Vapor System for the Treatment of Excessive Uterine Bleeding
Aegea Medical, Inc.29 sites in 4 countries230 target enrollmentStarted: February 1, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 230
- Locations
- 29
- Primary Endpoint
- Primary Effectiveness Endpoint
Study Overview
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)
Detailed Description
This is a single-arm, multi-center study with three years of follow-up.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- •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
Outcomes
Primary Outcomes
Primary Effectiveness Endpoint
Time Frame: 12 months
Reduction of menstrual blood loss
Secondary Outcomes
- Secondary Effectiveness Endpoint(12 months)
Investigators
Study Sites (29)
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