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

Minerva Surgical, Inc.3 sites in 1 country63 target enrollmentJune 2011

ConditionsMenorrhagia Due to Benign Causes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Menorrhagia Due to Benign Causes
Sponsor: Minerva Surgical, Inc.
Enrollment: 63
Locations: 3
Primary Endpoint: Reduction in Menstrual Blood Loss to Normal Levels at 12 Months
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 2011

End Date

June 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Minerva Surgical, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

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)

Outcomes

Primary Outcomes

Reduction in Menstrual Blood Loss to Normal Levels at 12 Months

Time Frame: 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.