A Two-Phase Clinical Study of the Minerva AURORA Ablation System

The primary objective of this study is to evaluate the use of the Aurora Ablation System in reducing menstrual blood loss at 12 months post-treatment. The occurrence of adverse events will be assessed along with an assessment of the reduction of uterine bleeding as measured by a pictorial blood loss assessment chart (PBLAC) or menstrual diary.

Study Overview

• Status: Completed
• Conditions: Menorrhagia Due to Benign Causes
• Intervention / Treatment: Device: Aurora Endometrial Ablation System

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1115
    • Szt Imre Hospital
  • Csongrad
    • Szeged, Csongrad, Hungary, 6725
      • University of Szeged
  • Hajdú-Bihar
    • Debrecen, Hajdú-Bihar, Hungary, 4043
      • Kenézy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Refractory menorrhagia with no definable organic cause (abnormal uterine bleeding)
2. Female subject from age 35 to 50 years
3. Uterine sound measurement of 6.0cm to 10.0cm (external os to internal fundus)

4. 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

   1. had at least 3 prior months documented failed medical therapy; or
   2. had a contraindication to medical therapy; or
   3. refused medical therapy
5. Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/ml
6. Not pregnant and no desire to conceive at any time
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

Exclusion Criteria:

1. Pregnancy or subject with a desire to conceive
2. Complex endometrial hyperplasia as confirmed by histology
3. Presence of active endometritis
4. Active pelvic inflammatory disease
5. Active sexually transmitted disease (STD)
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
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., transmural 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
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)
18. Subject currently on hormonal birth control therapy or unwilling to use a non-hormonal birth control post-ablation.
19. Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject
20. Any subject who is participating in any other research of an investigational drug or device that has not yet completed the primary endpoint evaluation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aurora Treatment Arm; Endometrial Ablation	Device: Aurora Endometrial Ablation System; Ablation of the endometrial lining of the uterus using the Aurora System

What is the study measuring?

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. A score of 0 represents no bleeding.	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.	Day of procedure

Collaborators and Investigators

• Sponsor: Minerva Surgical, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: January 10, 2014
• First Submitted That Met QC Criteria: January 10, 2014
• First Posted (Estimate): January 14, 2014

Study Record Updates

• Last Update Posted (Estimate): October 23, 2015
• Last Update Submitted That Met QC Criteria: September 23, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Menorrhagia; Excessive Uterine Bleeding; Endometrial Ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Menstruation Disturbances; Uterine Hemorrhage; Menorrhagia
• Other Study ID Numbers: CIP0001