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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01569763
Recruitment Status : Completed
First Posted : April 3, 2012
Results First Posted : May 5, 2016
Last Update Posted : April 18, 2018
Information provided by (Responsible Party):
Minerva Surgical, Inc.

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.

Condition or disease Intervention/treatment Phase
Menorrhagia Device: Aurora Endometrial Ablation Device: Rollerball Ablation/Resection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Minerva Pivotal Study
Study Start Date : March 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : March 2, 2018

Arm Intervention/treatment
Active Comparator: hysteroscopic rollerball resection/ablation Device: Rollerball Ablation/Resection
Hysteroscopic rollerball resection/ablation

Experimental: Aurora Endometrial Ablation Device: Aurora Endometrial Ablation
Endometrial Ablation using the Aurora Endometrial Ablation system

Primary Outcome Measures :
  1. Reduction of Menstrual Bleeding to Normal or Below Normal at 12 Months [ Time Frame: 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.

Secondary Outcome Measures :
  1. Procedure Time [ Time Frame: < 1 hour ]
    Procedure time is defined as the time from device insertion to time of device removal.

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01569763

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United States, Arizona
New Horizons Women's Care
Chandler, Arizona, United States, 85224
Women's Health Research
Phoenix, Arizona, United States, 85015
United States, Indiana
Basinski, LLC
Newburgh, Indiana, United States, 47630
United States, Kansas
Cypress Medical Research Center, LLC
Wichita, Kansas, United States, 67226
United States, Minnesota
Minnesota Gynecology and Surgery
Edina, Minnesota, United States, 55435
United States, Missouri
Mercy Clinic Minimally Invasive Gynecology
Saint Louis, Missouri, United States, 63141
United States, Tennessee
Tennessee Women's Care PC
Nashville, Tennessee, United States, 37203
United States, Texas
Baylor Research Institute
Fort Worth, Texas, United States, 76104
Canada, Ontario
McMaster University/Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N3Z5
Canada, Quebec
Hôpital LaSalle
Ville Lassalle, Quebec, Canada, H8P 1C1
Canada, Saskatchewan
Regina Qu'Appelle Health Region
Regina, Saskatchewan, Canada, S4S 6X3
La Cite Medicale
Quebec, Canada, G1W 2J5
Hospital Universitario, UANL
Monterrey, Nuevo Leon, Mexico, 64460
Sponsors and Collaborators
Minerva Surgical, Inc.
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Study Director: Eugene Skalnyi, MD Minerva Surgical, Inc.
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Responsible Party: Minerva Surgical, Inc. Identifier: NCT01569763    
Other Study ID Numbers: CIP0005
First Posted: April 3, 2012    Key Record Dates
Results First Posted: May 5, 2016
Last Update Posted: April 18, 2018
Last Verified: March 2018
Keywords provided by Minerva Surgical, Inc.:
endometrial ablation
Additional relevant MeSH terms:
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Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Pathologic Processes
Menstruation Disturbances