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

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

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