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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P230002 / PAS001 |
| Date Original Protocol Accepted |
07/28/2023
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| Date Current Protocol Accepted |
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| Study Name |
EASE Clinical Trial
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| Device Name |
Minitouch 3.8 Era System (Minitouch 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 |
Objective Performance Criterion
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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 |
To evaluate the safety and effectiveness of the Minitouch System for treatment of menorrhagia due to benign causes in premenopausal women for whom childbearing is complete.
Prospective, single-arm, non-randomized, multi-center clinical trial
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| Sample Size |
114
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| Key Study Endpoints |
At least 85% of the current patient cohort must be followed out to 36 months post procedure. The following outcomes will be provided:
Need for surgical or medical intervention to treat abnormal bleeding
Subject self-report of pregnancy
Contraception status (data to be collected at 3 years only)
Menstrual status
Gynecologic adverse events
Quality of Life Questionnaire
Patient Satisfaction
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| Follow-up Visits and Length of Follow-up |
36 months
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
114
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| Actual Number of Sites Enrolled |
7
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| Patient Follow-up Rate |
93.9% (107/114) through 36 months
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| Final Safety Findings |
There were 22 gynecologic adverse events (AEs) from 12-month to 36-month. There were zero (0) incidences of device or procedure-related serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) through the 36-month follow-up.
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| Final Effect Findings |
PREMARKET EFFECTIVENESS ENDPOINTS
At 12-month, the overall success rate based on PBLAC results was 89.5% (102/114), and the amenorrhea rate was 43.9% (50/114).
POSTMARKET EFFECTIVENESS ENDPOINTS:
Need for surgical or medical intervention to treat abnormal bleeding: From 12-month to 36-month, 2.6% (3/114) of the subjects had medical or surgical intervention to treat abnormal menstrual bleeding.
Subject Self-report of Pregnancy: From 12-month to 36-month, there were zero (0) incidences of pregnancy.
Menorrhagia Impact Questionnaire (MIQ): From 12-month to 36-month, most of the subjects reported no limitations, due to menstrual bleeding, in work (MIQ 2), physical activity (MIQ 3), and social/leisure (MIQ 4) activities at a rate of 90.2% (102/112), 87.5% (98/112) and 90.2% (101/112), respectively, at 24-month; and most of the subjects also reported no limitations, due to menstrual bleeding, in work (MIQ 2), physical activity (MIQ 3), and social/leisure (MIQ 4) activities at a rate of 93.5% (100/107), 93.5% (100/107), and 95.3% (102/107), respectively, at 36-month.
Dysmenorrhea-related Pain: From 12-month to 36-month, 92.0% (103/112) of the subjects reported a reduction in dysmenorrhea symptoms at 24-month; and 91.6% (98/107) of the subjects reported a reduction in dysmenorrhea symptoms at 36-month.
Patient Global Evaluation (PGE): From 12-month to 36-month, 90.2% (101/112) of the subjects were very satisfied or satisfied with the treatment received, and 90.2% (101/112) of the subjects would recommend the procedure to friends at 24-month; and 90.7% (97/107) of the subjects were very satisfied or satisfied with the treatment received, and 88.8% (95/107) of the subjects would recommend the procedure to friends at 36-month
Investigator Global Evaluation (IGE): From 12-month to 36-month, the investigators assessed the subjects menstrual status as normal (eumenorrhea) or less than normal (hypomenorrhea, spotting and amenorrhea) menstrual blood loss in 96.4% (108/112) of the subjects at 24-month; and the investigators assessed the subjects menstrual status as normal (eumenorrhea) or less than normal (hypomenorrhea, spotting and amenorrhea) menstrual blood loss in 95.3% (102/107) of the subjects at 36-month.
Contraception Status: At 36-month, subjects (N=107) reported use of the following contraception methods.
Abstinence: 4.7% (5/107)
Cervical Cap: 0.0% (0/107)
Condom: 19.6% (21/107)
Diaphragm: 0.0% (0/107)
Partner’s vasectomy: 44.9% (48/107)
Tubal sterilization: 28.0% (30/107)
Spermicidal vaginal sponge: 0.0% (0/107)
Sterile: 0.0% (0/107)
Hormonal method (includes pills, injections, patches, rings, implants): 3.7% (4/107)
Intrauterine devices: 1.9% (2/107)
Other: 4.7% (5/107)
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| Study Strengths & Weaknesses |
N/A
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| Recommendations for Labeling Changes |
Include final PAS data in the physician and patient labeling
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