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

NCT ID: NCT01569763

Last Updated: 2018-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2018-03-02

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.

Detailed Description

Menorrhagia is defined as menstrual bleeding in the ovulatory woman exceeding 80 ml per month. Approximately 20-25% of healthy premenopausal women have abnormal uterine bleeding. Menorrhagia can have a negative impact on a woman's lifestyle and self-perception, often leading her to seek definitive treatment. Pharmacologic treatment for menorrhagia is not always successful, and dilatation and curettage typically provides relief for only a few menstrual cycles. Traditionally hysterectomy has been the definitive treatment for menorrhagia. This clinical study evaluates the safety and effectiveness of the Aurora Endometrial Ablation System to provide a therapeutic treatment for menorrhagia due to benign causes by ablating the endometrial lining of the uterus in pre-menopausal women for whom childbearing is complete. Subjects who are randomized to the control group will receive hysteroscopic rollerball/resection ablation. Subjects randomized to the test arm will be treated with the Aurora Endometrial Ablation System.

Conditions

Menorrhagia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

hysteroscopic rollerball resection/ablation

Group Type: ACTIVE_COMPARATOR

Rollerball Ablation/Resection

Intervention Type: DEVICE

Hysteroscopic rollerball resection/ablation

Aurora Endometrial Ablation

Group Type: EXPERIMENTAL

Aurora Endometrial Ablation

Intervention Type: DEVICE

Endometrial Ablation using the Aurora Endometrial Ablation system

Interventions

Aurora Endometrial Ablation

Endometrial Ablation using the Aurora Endometrial Ablation system

Intervention Type: DEVICE

Rollerball Ablation/Resection

Hysteroscopic rollerball resection/ablation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

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)
• 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
• Abnormal or obstructed cavity as confirmed by hysteroscopy, SIS or vaginal ultrasound
• Presence of an intrauterine device (IUD) which the Subject is unwilling to have removed at the time of the operative visit
• Subject currently on hormonal birth control therapy (including the Mirena device) for <3 months prior to enrollment
• Subject who is unwilling to use birth control post-ablation whether non-hormonal birth control or the same hormonal birth control therapy as before the procedure
• Subject who is within 6-weeks post partum
• Any subject who is currently participating or considers future participation in a research study of an investigational drug or device during the course of this investigational study
• Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Minerva Surgical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eugene Skalnyi, MD

Role: STUDY_DIRECTOR

Minerva Surgical, Inc.

Locations

New Horizons Women's Care

Chandler, Arizona, United States

Women's Health Research

Phoenix, Arizona, United States

Basinski, LLC

Newburgh, Indiana, United States

Cypress Medical Research Center, LLC

Wichita, Kansas, United States

Minnesota Gynecology and Surgery

Edina, Minnesota, United States

Mercy Clinic Minimally Invasive Gynecology

St Louis, Missouri, United States

Tennessee Women's Care PC

Nashville, Tennessee, United States

Baylor Research Institute

Fort Worth, Texas, United States

McMaster University/Hamilton Health Sciences

Hamilton, Ontario, Canada

La Cite Medicale

Québec, Quebec, Canada

Hôpital LaSalle

Ville Lassalle, Quebec, Canada

Regina Qu'Appelle Health Region

Regina, Saskatchewan, Canada

Hospital Universitario, UANL

Monterrey, Nuevo León, Mexico

Countries

United States; Canada; Mexico

Other Identifiers

CIP0005

Identifier Type: -

Identifier Source: org_study_id