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

Completed · Not applicable

Conditions studied: Menorrhagia

In brief

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.

Key facts

Study ID

NCT01569763

Run by

Minerva Surgical, Inc.

People needed

153

Starts

2012-03-01

Expected to finish

2018-03-02

Last updated by the study team

2018-04-18

Who can join

Age: 25 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

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
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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