Minerva Pivotal Study to Evaluate Safety and Efficacy of the Aurora Endometrial Ablation System Compared to Hysteroscopic Rollerball Ablation

NCT01569763 | Completed Results DMC

• 1 other identifier: CIP0005
• Study Type: interventional
• Target: 153
• Locations: 3 countries
• Sites: 13

Brief Summary

The primary objective of this study is to evaluate the safety and effectiveness of the Aurora Endometrial Ablation System as compared to hysteroscopic rollerball endometrial ablation in reducing menstrual blood loss at 12 months post-treatment.

Conditions

Menorrhagia

Keywords

endometrial ablation

Outcome Measures

Primary Outcomes (1)

• Reduction of Menstrual Bleeding to Normal or Below Normal at 12 Months

  Clinical success was defined as a reduction in menstrual bleeding volume to ≤ 80 ml as measured by the alkaline hematin method (AH). Clinical success was not achieved if: (1) at one year post-treatment menstrual blood loss is greater than 80ml, as measured by AH; (2) an acute failure occurred (e.g., aborted procedure, etc.); or (3) the subject required additional therapy to control menorrhagia.

  12 months

Secondary Outcomes (1)

• Procedure Time

  < 1 hour

Study Arms (2)

hysteroscopic rollerball resection/ablation

ACTIVE COMPARATOR

Device: Rollerball Ablation/Resection

Aurora Endometrial Ablation

EXPERIMENTAL

Device: Aurora Endometrial Ablation

Interventions

Aurora Endometrial Ablation DEVICE

Endometrial Ablation using the Aurora Endometrial Ablation system

Aurora Endometrial Ablation

Rollerball Ablation/Resection DEVICE

Hysteroscopic rollerball resection/ablation

hysteroscopic rollerball resection/ablation

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 (and including) age 25 to 50 years
• Uterine sound measurement of no greater than10.0cm (external os to internal fundus) and a minimum uterine cavity length of 4.0cm
• A minimum menstrual blood loss of ≥ 160 ml for two baseline cycles within three months prior to treatment as measured by alkaline hematin extraction; OR,
• A minimum menstrual blood loss of ≥ 160 ml for one baseline cycle for women who either
• had at least 3 prior months documented failed medical therapy; or
• had a contraindication to medical therapy
• Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/L
• Not pregnant and no desire to conceive at any time
• Subject agrees to use a reliable form of contraception up to the 12-month follow-up visit. If a hormonal birth control method is used for contraception, the subject must have been on said method for ≥ 3 months prior to enrollment and agrees to remain on the same hormonal regimen through the initial 12-month follow-up
• 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 requirements
• Subject who is literate or demonstrates an understanding on how to collect menstrual blood loss products for the alkaline hematin method of analysis

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)
• 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 abdominal pelvic or gynecological malignancy within the past 5 years
• Known clotting defects or bleeding disorders
• Untreated/unevaluated cervical dysplasia, except CIN I
• 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
• Presence of an implantable (intrauterine) contraceptive device (e.g. Essure™ or Adiana™)
• 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 (13)

New Horizons Women's Care

Chandler, Arizona, 85224, United States

Location

Women's Health Research

Phoenix, Arizona, 85015, United States

Location

Basinski, LLC

Newburgh, Indiana, 47630, United States

Location

Cypress Medical Research Center, LLC

Wichita, Kansas, 67226, United States

Location

Minnesota Gynecology and Surgery

Edina, Minnesota, 55435, United States

Location

Mercy Clinic Minimally Invasive Gynecology

St Louis, Missouri, 63141, United States

Location

Tennessee Women's Care PC

Nashville, Tennessee, 37203, United States

Location

Baylor Research Institute

Fort Worth, Texas, 76104, United States

Location

McMaster University/Hamilton Health Sciences

Hamilton, Ontario, L8N3Z5, Canada

Location

La Cite Medicale

Québec, Quebec, G1W 2J5, Canada

Location

Hôpital LaSalle

Ville Lassalle, Quebec, H8P 1C1, Canada

Location

Regina Qu'Appelle Health Region

Regina, Saskatchewan, S4S 6X3, Canada

Location

Hospital Universitario, UANL

Monterrey, Nuevo León, 64460, Mexico

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

Study Officials

• Eugene Skalnyi, MD

  Minerva Surgical, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: March 30, 2012
• First Posted: April 3, 2012
• Study Start: March 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: March 2, 2018
• Last Updated: April 18, 2018
• Results First Posted: May 5, 2016

Record last verified: 2018-03

Locations

US (8); ME (1); CA (4)