A Single Arm Clinical Study of the Safety and Efficacy of the AURORA™ Endometrial Ablation System

Inclusion criteria

• Refractory menorrhagia with no definable organic cause
• Female subject from age 25 to 50 years
• Uterine sound measurement of 6.0cm to 10.0cm (external os to internal fundus)
• One of the following criteria:

A. Documented history of menorrhagia secondary to dysfunctional uterine bleeding (DUB).

B. If a pictorial blood loss assessment chart (PBLAC) scoring systems is used; a minimum PBLAC score of ≥150 for 3 months prior to study enrollment; OR, A minimum PBLAC score ≥150 for one month for women who either i. had at least 3 prior months documented failed medical therapy; or ii. had a contraindication to medical therapy; or iii. refused medical therapy

• Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/ml
• Not pregnant and no desire to be pregnant in the future
• Patient agrees not to use hormonal contraception or any other medical intervention for bleeding during the study
• Able to provide written informed consent using a form that has been approved by the reviewing IRB/EC
• Subject agrees to follow-up exams and data collection, including ability to accurately use menstrual diaries
• Subject who is literate or demonstrates an understanding on how to use menstrual diaries or how to collect and provide used sanitary products

Exclusion criteria

• Pregnancy or subject with a desire to conceive
• Endometrial hyperplasia as confirmed by histology
• Presence of active endometritis
• Active pelvic inflammatory disease
• Active sexually transmitted disease (STD), at the time of ablation. Note: Treatment of STD documented in the chart serves as sufficient evidence of infection resolution. Patient may be considered for study enrollment.
• Presence of bacteremia, sepsis, or other active systemic infection
• Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of the procedure
• Known/suspected gynecological malignancy within the past 5 years
• Known clotting defects or bleeding disorders
• Untreated/unevaluated cervical dysplasia (except CIN I)
• Known/suspected abdominal/pelvic cancer
• Prior uterine surgery (except low segment cesarean section) that interrupts the integrity of the uterine wall (e.g., myomectomy or classical cesarean section)
• Previous endometrial ablation procedure
• Currently on medications that could thin the myometrial muscle, such as long-term steroid use (except inhaler or nasal therapy for asthma)
• Currently on anticoagulants
• Abnormal or obstructed cavity as confirmed by hysteroscopy or SIS, specifically:

• Septate or bicornuate uterus or other congenital malformation of the uterine cavity
• Pedunculated or submucosal myomas distorting the uterine cavity
• Polyps likely to be the cause of the subject's menorrhagia
• Intramural or subserosal myomas that distort the uterine cavity
• Presence of an intrauterine device (IUD) which the patient is unwilling to have removed at the time of the operative visit
• Presence of an implantable contraceptive device (e.g. Essure or Adiana).
• Subject currently on hormonal birth control therapy or unwilling to use a non-hormonal birth control post-ablation (including a Mirena device).
• Subject who is within 6-weeks post partum.
• Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject
• Any subject who is currently participating or considers future participation in any other research of an investigational drug or device.