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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Minerva Surgical, Inc.
ClinicalTrials.gov Identifier:
NCT01569763
First received: March 30, 2012
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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 Intervention
Menorrhagia
Device: Aurora Endometrial Ablation
Device: Rollerball Ablation/Resection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Minerva Pivotal Study

Resource links provided by NLM:


Further study details as provided by Minerva Surgical, Inc.:

Primary Outcome Measures:
  • reduction of menstrual bleeding [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events associated with the two study groups [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Comparison of procedure time between the two groups [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 153
Study Start Date: March 2012
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   25 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01569763

Locations
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
St. Louis, Missouri, United States, 63141
United States, Tennessee
Tennessee Women's Care PC
Nashville, Tennessee, United States, 37203
United States, Texas
Baylor Research Institute
Ft. Worth, Texas, United States, 76104
Canada, Ontario
McMaster University/Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N3Z5
Canada, Quebec
Hôpital LaSalle
Ville Lassalle (Montreal area), Quebec, Canada, H8P 1C1
Canada, Saskatchewan
Regina Qu'Appelle Health Region
Regina, Saskatchewan, Canada, S4S 6X3
Canada
La Cite Medicale
Quebec, Canada, G1W 2J5
Mexico
Hospital Universitario, UANL
Monterrey, Nuevo Leon, Mexico, 64460
Sponsors and Collaborators
Minerva Surgical, Inc.
Investigators
Study Director: Eugene Skalnyi, MD Minerva Surgical, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Minerva Surgical, Inc.
ClinicalTrials.gov Identifier: NCT01569763     History of Changes
Other Study ID Numbers: CIP0005
Study First Received: March 30, 2012
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Mexico: Ministry of Health

Keywords provided by Minerva Surgical, Inc.:
endometrial ablation

Additional relevant MeSH terms:
Menorrhagia
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014