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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P140013 / PAS001 |
| Date Original Protocol Accepted |
07/27/2015
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| Date Current Protocol Accepted |
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| Study Name |
Minerva Single-Arm Study
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| Device Name |
MINERVA ENDOMETRIAL ABLATION SYSTEM
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The Minerva Single-Arm Study is a single-arm, non-randomized, 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.
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| Study Population |
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.
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| Sample Size |
Up to 110 women
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| Key Study Endpoints |
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
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| Follow-up Visits and Length of Follow-up |
Three years
One year (data were provided premarket), two year, and three year
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
110 subjects
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| Actual Number of Sites Enrolled |
7 study sites
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| Patient Follow-up Rate |
12 month follow-up: 104/110 subjects (94.5%)
24 month follow-up: 72/101 subjects (71.3%)
36 month follow-up: 93/101 subjects (92.1%)
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| Final Safety Findings |
There were a total of 199 adverse events, including one serious adverse event (SAE) and 198 non-serious adverse events, reported at the 2-4 weeks, 3 month, 6 month, and 12 month follow-up. There was one report of pregnancy at the 12 month follow-up. There was one serious adverse event (SAE) and 11 non-serious gynecological adverse events reported at the 2- and 3-year follow-up. The one SAE was due to pelvic pain in one subject which was not determined to be device or procedure-related. There were no unanticipated device-related adverse events in the study through the 3-year follow-up
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| Final Effect Findings |
Primary effectiveness endpoint: The overall success rate based on PBLAC results was 91.8% (101/110) at 12 months.
Other effectiveness endpoints: At 12 months 80.8% of subjects responded that they observed a decrease in pre-menstrual symptoms, 54.8% observed a decrease in dysmenorrhea, 97.6% reported satisfied or very satisfied with the procedure, and 98.8% of subjects responded that they would recommend the procedure based on the Menstrual Impact Questionnaire (MIQ). At 24 months and 36 months the overall success rate (reported by blood loss assessment of eumenorrhea or less) was 92.1% and 93.1%, respectively. At 24 months and 36 months 97.2% and 98.9% of subjects reported being satisfied or very satisfied with the procedure, respectively.
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| Recommendations for Labeling Changes |
Yes, labeling change recommended to update the device labeling with the final study results.
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