Clinical trial: A Single Arm Clinical Study of the Safety and Efficacy of the AURORA™ Endometrial Ablation System (NCT02023801)

Eligibility criteria:
Inclusion Criteria:

          1. Refractory menorrhagia with no definable organic cause

          2. Female subject from age 25 to 50 years

          3. Uterine sound measurement of 6.0cm to 10.0cm (external os to internal fundus)

          4. 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

          5. Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/ml

          6. Not pregnant and no desire to be pregnant in the future

          7. Patient agrees not to use hormonal contraception or any other medical intervention for
             bleeding during the study

          8. Able to provide written informed consent using a form that has been approved by the
             reviewing IRB/EC

          9. Subject agrees to follow-up exams and data collection, including ability to accurately
             use menstrual diaries

         10. 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:

          1. Pregnancy or subject with a desire to conceive

          2. Endometrial hyperplasia as confirmed by histology

          3. Presence of active endometritis

          4. Active pelvic inflammatory disease

          5. 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.

          6. Presence of bacteremia, sepsis, or other active systemic infection

          7. Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time
             of the procedure

          8. Known/suspected gynecological malignancy within the past 5 years

          9. Known clotting defects or bleeding disorders

         10. Untreated/unevaluated cervical dysplasia (except CIN I)

         11. Known/suspected abdominal/pelvic cancer

         12. Prior uterine surgery (except low segment cesarean section) that interrupts the
             integrity of the uterine wall (e.g., myomectomy or classical cesarean section)

         13. Previous endometrial ablation procedure

         14. Currently on medications that could thin the myometrial muscle, such as long-term
             steroid use (except inhaler or nasal therapy for asthma)

         15. Currently on anticoagulants

         16. Abnormal or obstructed cavity as confirmed by hysteroscopy or SIS, specifically:

               1. Septate or bicornuate uterus or other congenital malformation of the uterine
                  cavity

               2. Pedunculated or submucosal myomas distorting the uterine cavity

               3. Polyps likely to be the cause of the subject's menorrhagia

               4. Intramural or subserosal myomas that distort the uterine cavity

         17. Presence of an intrauterine device (IUD) which the patient is unwilling to have
             removed at the time of the operative visit

         18. Presence of an implantable contraceptive device (e.g. Essure or Adiana).

         19. Subject currently on hormonal birth control therapy or unwilling to use a non-hormonal
             birth control post-ablation (including a Mirena device).

         20. Subject who is within 6-weeks post partum.

         21. Any general health condition which, in the opinion of the Investigator, could
             represent an increased risk for the subject

         22. Any subject who is currently participating or considers future participation in any
             other research of an investigational drug or device.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
Subject must be at most 50 Years

Patient description (medical language): A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years.

Patient description (patient's own words): I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL.

Does the patient match the trial criteria? Contradiction