A Single Arm Clinical Study of the Safety and Efficacy of the AURORA™ Endometrial Ablation System
This trial is active, not recruiting.
|Condition||menorrhagia due to benign causes|
|Treatment||aurora endometrial ablation system|
|Sponsor||Minerva Surgical, Inc.|
|Start date||August 2011|
|End date||October 2012|
|Trial size||24 participants|
|Trial identifier||NCT02023801, CIP0004|
This is a clinical study without a formal hypothesis. The primary objective of the study is to evaluate the use of the Aurora Endometrial Ablation System in achieving a return to normal menstrual blood loss at 12 months post-treatment, in premenopausal women with menorrhagia due to benign causes for whom childbearing is complete or no longer wish to retain fertility.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
time frame: 12 Months
Occurrence of adverse events
time frame: 12 months
Long-Term Subject follow-up
time frame: 3 years
Female participants from 25 years up to 50 years old.
- 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
- 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.
|Official title||A Single Arm Clinical Study of the Safety and Efficacy of the AURORA™ Endometrial Ablation System|
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