A Multi-Center, Single Arm Clinical Study of the Safety and Efficacy of the AURORA™ Endometrial Ablation System

Study Overview
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Brief Summary
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This is a multi-center, single-arm, non-randomized, prospective clinical study. The clinical study is designed as a non-inferiority study to assess the effectiveness of the Aurora Endometrial Ablation System compared to an objective standard. Safety will be evaluated by determining the number and percentage of subjects who experience one or more of serious adverse events.

Official Title
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A Multi-Center, Single Arm Clinical Study of the Safety and Efficacy of the AURORA™ Endometrial Ablation System

Conditions
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Menorrhagia Due to Benign Causes

Intervention / Treatment
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* Device: Aurora Endometrial Ablation System


Participation Criteria
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Eligibility Criteria
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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 1 month prior to study enrollment. 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 for PBLAC analysis. Subject who is literate or demonstrates an understanding on how to use menstrual diaries. 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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aurora Treatment Arm<br>Endometrial Ablation | Device: Aurora Endometrial Ablation System<br>* Ablation of the endometrial lining of the uterus using the Aurora System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Menstrual Blood Loss to Normal Levels at 12 Months | Number of subjects in whom menstrual blood loss was reduced to normal or below normal levels at 12 months, as measured by a pictorial blood loss assessment chart (PBLAC) score of <=75. | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Time | Procedure Time defined as time from insertion of the Disposable Handpiece to the time of removal. | < 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menorrhagia, Excessive uterine bleeding, Endometrial Ablation