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

Menorrhagia Due to Benign Causes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02023801
• Other study ID #: CIP0004
• Status: Completed
• Phase: N/A
• First received: December 24, 2013
• Last updated: October 6, 2015
• Start date: August 2011
• Est. completion date: May 2015

Study information

• Verified date: October 2015
• Source: Minerva Surgical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics CommitteeMexico: Federal Commission for Sanitary Risks ProtectionMexico: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2015
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menorrhagia
• Menorrhagia Due to Benign Causes

Intervention

Device:
• Aurora Endometrial Ablation System
Ablation of the endometrial lining of the uterus using the Aurora System

Locations

Country	Name	City	State
Mexico	Hospital Universitario, UANL	Monterrey	Nuevo Leon

Sponsors (1)

Lead Sponsor	Collaborator
Minerva Surgical, Inc.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Procedure Time	Procedure time defined as time from insertion of the Disposable Handpiece to the time of removal	< 1 hour	No