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

March 20, 2018 updated by: Minerva Surgical, Inc.

Minerva Pivotal Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
153

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1W 2J5
        • La Cite Medicale
    • Ontario
      • Hamilton, Ontario, Canada, L8N3Z5
        • McMaster University/Hamilton Health Sciences
    • Quebec
      • Ville Lassalle, Quebec, Canada, H8P 1C1
        • Hôpital Lasalle
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4S 6X3
        • Regina Qu'Appelle Health Region
  • Mexico
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Hospital Universitario, UANL
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • New Horizons Women's Care
      • Phoenix, Arizona, United States, 85015
        • Women's Health Research
    • Indiana
      • Newburgh, Indiana, United States, 47630
        • Basinski, LLC
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Cypress Medical Research Center, LLC
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Minnesota Gynecology and Surgery
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Mercy Clinic Minimally Invasive Gynecology
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Women's Care PC
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Baylor Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Procedure Time
Time Frame: < 1 hour
Procedure time is defined as the time from device insertion to time of device removal.
< 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Minerva Surgical, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Eugene Skalnyi, MD, Minerva Surgical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 2, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CIP0005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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