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

NCT02035332 | Completed Results DMC

• 1 other identifier: CIP0001
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Menorrhagia Due to Benign Causes

Keywords

Excessive Uterine Bleeding; Menorrhagia; 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. A score of 0 represents no bleeding.

  12 Months

Secondary Outcomes (1)

• Procedure Time

  Day of procedure

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

You may qualify if:

• Refractory menorrhagia with no definable organic cause (abnormal uterine bleeding)
• Female subject from age 35 to 50 years
• Uterine sound measurement of 6.0cm to 10.0cm (external os to internal fundus)
• 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
• had at least 3 prior months documented failed medical therapy; or
• had a contraindication to medical therapy; or
• refused medical therapy
• Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/ml
• Not pregnant and no desire to conceive at any time
• 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

You may not qualify if:

• Pregnancy or subject with a desire to conceive
• Complex endometrial hyperplasia as confirmed by histology
• Presence of active endometritis
• Active pelvic inflammatory disease
• Active sexually transmitted disease (STD)
• 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
• Known/suspected abdominal/pelvic cancer
• Prior uterine surgery (except low segment cesarean section) that interrupts the integrity of the uterine wall (e.g., transmural myomectomy or classical cesarean section)
• Previous endometrial ablation procedure
• Currently on medications that could thin the myometrial muscle, such as long-term steroid use
• Currently on anticoagulants

Sponsors & Collaborators

• Minerva Surgical, Inc.: lead

Study Sites (3)

Szt Imre Hospital

Budapest, Budapest, 1115, Hungary

Location

University of Szeged

Szeged, Csongrád megye, 6725, Hungary

Location

Kenézy Hospital

Debrecen, Hajdú-Bihar, 4043, Hungary

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 10, 2014
• First Posted: January 14, 2014
• Study Start: May 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: February 1, 2015
• Last Updated: October 23, 2015
• Results First Posted: October 23, 2015

Record last verified: 2015-09

Locations

HU (3)