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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Minerva Pivotal Study


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General
Study Status Completed
Application Number P140013 / PAS002
Date Current Protocol Accepted 07/25/2015
Study Name Minerva Pivotal Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The Minerva Pivotal Study is a randomized (2:1), controlled, multicenter study to evaluate the safety and effectiveness of the Minerva Endometrial Ablation System. The Post Approval study will collect extended effectiveness and safety data at 2-3 years post treatment.
Study Population Description Pre-menopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete or who no longer wish to retain fertility.

The premarket study included a rollerball control group.

Sample Size Up to 162 women (108 treatment arm and 54 control arm)
Data Collection Any treatments or hysterectomy for dysfunctional uterine bleeding

Compliance with contraception

Any pregnancies

Menstrual status (questions assess bleeding, i.e., amenorrhea, spotting hypomenorrhea, eumenorrhea or menorrhagia)

Any gynecological adverse events

Completion of Quality of Life Questionnaire

Follow-up Visits and Length of Follow-up Three years

30 days (data were provided premarket), one year, two year, and three year

Interim or Final Data Summary
Actual Number of Patients Enrolled 153 subjects were enrolled in the study
Actual Number of Sites Enrolled 13 sites were enrolled in the study
Patient Follow-up Rate The 3-year follow-up rate was 125/153 total subjects (81.7%). This included 88/102 subjects (86.3%) in the Minerva treatment arm and 37/51 subjects (72.5%) in the Rollerball control arm.
Final Safety Findings There were no unexpected device-related adverse events in the Minerva Pivotal study. There were five events classified as Serious Adverse Events (SAEs) in the Minerva Group. The SAEs were as follows:



Four Hysterectomies were performed, two (2) for pelvic cramping, one (1) for fibroids and one (1) for chronic pelvic pain secondary to a diagnosis of hematometra.



One pregnancy was reported between the 12- and 24-month reporting period. A Dilation and Curettage (D&C) was performed to terminate the pregnancy.

Final Effect Findings Success Rate

The following success rates were reported at 1, 2, and 3 years in the intent-to-treat (ITT) population:



1 year*

Minerva (N=102): 95 (93.1%); 95% CI (86.4%, 97.2%)

Rollerball (N=51): 41 (80.4%); 95% CI (66.9%, 90.2%)



2 years**

Minerva (N=102): 89 (87.3%); 95% CI (79.2%, 93.0%)

Rollerball (N=51): 35 (68.6%); 95% CI (54.1%, 80.9%)



3 years**

Minerva (N=102): 87 (85.3%); 95% CI (76.9%, 91.5%)

Rollerball (N=51): 35 (68.6%); 95% CI (54.1%, 80.9%)



*Based on Alkaline Hematase lab value

**Based on telephone questionnaires

Amenorrhea Rate

The following amenorrhea rates were reported at 1 and 3 years in the intent-to-treat (ITT) population:



1 year

Minerva (N=102): 73 (71.6%); 95% CI (61.8%, 80.1%)

Rollerball (N=51): 25 (49.0%); 95% CI (34.8%, 63.4%)



3 years*

Minerva (N=102): 58 (56.9%); 95% CI (46.7%, 66.6%)

Rollerball (N=51): 19 (37.3%); 95% CI (24.1%, 51.9%)



*Mean follow-up time of 4.1 years



Subject Satisfaction

At 2- and 3-year follow-up, 93.4% and 95.5% of the Minerva subjects, respectively compared to 92.1% and 89.2% of the Rollerball subjects, respectively were “Satisfied” or “Very Satisfied” post-procedure. In addition, at the 2- and 3-year follow-up, 94.6% and 95.4% of the Minerva subjects, respectively compared to 94.8% and 91.9% of Rollerball subjects, respectively would “Maybe” or “Definitely” recommend the procedure to a friend or relative with a similar problem

Study Strengths & Weaknesses N/A
Recommendations for Labeling Changes Yes, labeling change recommended to update the device labeling with the final study results.


Minerva Pivotal Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 07/26/2016 12/07/2015 On Time
two year report/final 07/26/2017 07/20/2017 On Time


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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