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

NCT02029911 | Completed Results DMC

• 1 other identifier: CIP0003
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 3

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.

Conditions

Menorrhagia Due to Benign Causes

Keywords

Menorrhagia; Excessive uterine bleeding; Endometrial Ablation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Procedure Time

  < 1 hour

Study Arms (1)

Aurora Treatment Arm

EXPERIMENTAL

Endometrial Ablation

Device: Aurora Endometrial Ablation System

Interventions

Aurora Endometrial Ablation System DEVICE

Ablation of the endometrial lining of the uterus using the Aurora System

Aurora Treatment Arm

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Subject agrees to follow-up exams and data collection, including ability to accurately use menstrual diaries for PBLAC analysis.
• Subject who is literate or demonstrates an understanding on how to use menstrual diaries.

You may not qualify if:

• 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

Sponsors & Collaborators

• Minerva Surgical, Inc.: lead

Study Sites (3)

Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, H4J 1C5, Canada

Location

La Cite Medicale

Québec, Quebec, G1W 2J5, Canada

Location

Hôpital Lasalle

Ville Lassalle, Quebec, H8P 1C1, Canada

Location

MeSH Terms

Conditions

Menorrhagia

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Results Point of Contact

• Title: Dr. Eugene Skalnyi, VP Medical Affairs
• Organization: Minerva Surgical, Inc.

eugenes@minervasurgical.com

(1) 650-284-3500

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: January 8, 2014
• Study Start: June 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: June 1, 2015
• Last Updated: November 5, 2015
• Results First Posted: November 5, 2015

Record last verified: 2015-10

Locations

CA (3)