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

AEGEA Medical

Status and phase: Unknown; Phase 3

Conditions: Menorrhagia

Treatments: Device: AEGEA Vapor System(TM)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01979861

SE-3000

Details and patient eligibility

About

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)

Full description

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

Enrollment: 230 estimated patients

Sex: Female

Ages: 30 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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230 participants in 1 patient group

vapor endometrial ablation

Experimental group

Description:

endometrial ablation using the AEGEA Vapor System

Treatment:

Device: AEGEA Vapor System(TM)