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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P180032 / PAS001 |
| Date Original Protocol Accepted |
03/28/2019
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| Date Current Protocol Accepted |
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| Study Name |
CLARITY Clinical Post-Approval Study
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| Device Name |
Cerene® Cryotherapy Device
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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 |
Analytical
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This study is continued follow-up of the premarket cohort (i.e., continued enrollment). The study was an international, prospective, multi-center, single-arm, open label, non-randomized clinical study. The objective of the study was to evaluate the safety and effectiveness of the Cerene Cryotherapy Device in premenopausal women with heavy menstrual bleeding due to benign causes for whom childbearing was complete. There were 12 investigational sites that enrolled subjects and 11 that performed treatments, located in the United States, Mexico, and Canada. Treatments took place between June 2016 and March 2017.
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| Study Population |
Premenopausal women with heavy menstrual bleeding due to benign causes for whom childbearing was complete.
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| Sample Size |
Five hundred and fifty-four (554) subjects were enrolled in the study, with 242 proceeding to treatment and comprising the Intent-to-Treat (ITT) population. The primary safety and effectiveness outcomes were analyzed based on the ITT population.
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| Key Study Endpoints |
The primary safety endpoint was incidence of serious adverse events and serious device-related adverse events at 12 months.
The primary effectiveness endpoint was reduction in menstrual bleeding at 12 months; success was defined as a PBLAC score of = 75. The PBLAC is a self-administered instrument that allows the subject to record the number of menstrual products she used during her menstrual period. A PBLAC score is calculated from the number, type, and saturation level of menstrual products recorded on the diary.
Additional evaluations included amenorrhea rate at Month 12, subject-reported peri-procedural pain experience, evaluation of dysmenorrhea at Month 12, Quality of Life outcomes at Month 3, 6, and 12 using the Menorrhagia Impact Questionnaire (MIQ) and the Premenstrual Symptoms Impact Survey (PMSIS™), evaluation of uterine access and healing at 12 months post-procedure, and additional medical or surgical interventions for continued heavy menstrual bleeding through Month 36.
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| Follow-up Visits and Length of Follow-up |
36 months (3 years)
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| Interim or Final Data Summary |
| Interim Results |
Safety – after the Month 12 visit:
Eight (8) subjects exited due to additional interventions for menstrual bleeding. Three (3) subjects exited due to uterine pregnancy. Four (4) subjects voluntarily exited. One (1) subject exited prior to hysterectomy for pelvic pain.
There are 31 subjects reported gynecologic adverse events after the Month 12 follow-up visit none of which were related to the device and/or procedure. Two (2) events were serious adverse events as a result of hospitalization for hysterectomy.
At Month 12, the number of patients reported menorrhagia, dysmenorrhea, uterine fibroids, vaginal infection, and pregnancy was 9, 7, 2, 2, and 1, respectively.
Effectiveness – The outcomes at 24-month follow-up are:
Regarding quality of life (MIQ survey), 84 % subjects reported to experience limitation in their life at screening and this decreased to 10 % and 6% at the Month 12 and Month 24 respectively.
On the PMSIS, 75 % of subjects reported PMS symptoms at the screening and this decreased to 17 % and 19 % at the Month 12 and Month 24 respectively.
89.7 % of the subjects were satisfied or very satisfied with the procedure at Month 12 and 82.9 % at Month 24.
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| Actual Number of Patients Enrolled |
242
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| Actual Number of Sites Enrolled |
11
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| Patient Follow-up Rate |
12-month: 95.0% (230/242)
24-month: 90.5% (210/232)
36-month: 86.6% (201/232)
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| Final Safety Findings |
There were 49 gynecologic adverse events from 12 months to 36 months. There were no unanticipated device-related adverse events in the study through the 3-year follow-up. One (1) event, postcoital bleeding, was recorded as related to the procedure.
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| Final Effect Findings |
Premarket effectiveness endpoints: The overall success rate based on PBLAC results was 76.9% (186/242) at 12 months. The amenorrhea (no menses) rate was 10.3% (25/242).
Postmarket effectiveness endpoints:
Need for surgical or medical intervention to treat abnormal bleeding: From 12 to 36 months, 5.6% subjects (13/232) had medical or surgical intervention to treat abnormal menstrual bleeding.
Subject self-report of pregnancy: Three (3) subjects exited due to ongoing pregnancy. One (1) subject continued in the study following termination of her pregnancy.
Quality of Life: The Menorrhagia Impact Questionnaire (MIQ) that subjects experienced moderate, quite a bit, or extreme limitations in their social-leisure and/or physical activities and/or their ability to work is stablized from 10% (23/23) at Month 12 to 4.9% (8/163) at Month 24 and 9.5% (19/201) at the Month 36 follow-up visit.
Patient Satisfaction: The percentages of patients reporting very satisfied or satisfied were 84% (121/144) at 24 months and 84.5% (153/181) at 36 months. The percentages of patients who would recommend the procedure to a friend were 90% (135/150) at 24 months and 90.6% (175/193) at 36 months.
Contraception Status:
Method of Contraception 36 Month (N=201)
Surgical Tubal Ligation 90 (44.8%)
Vasectomy 69 (34.3%)
Condoms 20 (10%)
Abstinence 10 (5%)
Other 5 (2.5%)
IUD 3 (1.5%)
Same sec partner 3 (1.5%)
Rhythm or fertility awareness method
1 (0.5%)
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| Study Strengths & Weaknesses |
n/a
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