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

Not Applicable

Completed

Conditions: Menorrhagia

Interventions: Device: Aurora Endometrial Ablation
Device: Rollerball Ablation/Resection

Registration Number: NCT01569763

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 153

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aurora Endometrial Ablation	Aurora Endometrial Ablation	-
hysteroscopic rollerball resection/ablation	Rollerball Ablation/Resection	-

Primary Outcome Measures

Name	Time	Method
Reduction of Menstrual Bleeding to Normal or Below Normal at 12 Months	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

Name	Time	Method
Procedure Time	< 1 hour	Procedure time is defined as the time from device insertion to time of device removal.

Trial Locations

Locations (13): Women's Health Research
🇺🇸
Phoenix, Arizona, United States
New Horizons Women's Care
🇺🇸
Chandler, Arizona, United States
Basinski, LLC
🇺🇸
Newburgh, Indiana, United States
Minnesota Gynecology and Surgery
🇺🇸
Edina, Minnesota, United States
Tennessee Women's Care PC
🇺🇸
Nashville, Tennessee, United States
Mercy Clinic Minimally Invasive Gynecology
🇺🇸
Saint Louis, Missouri, United States
McMaster University/Hamilton Health Sciences
🇨🇦
Hamilton, Ontario, Canada
Hôpital LaSalle
🇨🇦
Ville Lassalle, Quebec, Canada
La Cite Medicale
🇨🇦
Quebec, Canada
Regina Qu'Appelle Health Region
🇨🇦
Regina, Saskatchewan, Canada
Hospital Universitario, UANL
🇲🇽
Monterrey, Nuevo Leon, Mexico
Cypress Medical Research Center, LLC
🇺🇸
Wichita, Kansas, United States
Baylor Research Institute
🇺🇸
Fort Worth, Texas, United States