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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P140013 / PAS002 |
| Date Original Protocol Accepted |
07/25/2015
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| Date Current Protocol Accepted |
07/25/2015
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| Study Name |
Minerva Pivotal 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 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.
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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.
The premarket study included a rollerball control group.
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| Sample Size |
Up to 162 women (108 treatment arm and 54 control arm)
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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
30 days (data were provided premarket), one year, two year, and three year
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
153 subjects were enrolled in the study
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| Actual Number of Sites Enrolled |
13 sites were enrolled in the study
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| 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.
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| 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.
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| 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
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| Study Strengths & Weaknesses |
N/A
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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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