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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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CLARITY Clinical Post-Approval Study

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Study Status Progress Adequate
Application Number P180032 / PAS001
Study Name CLARITY Clinical Post-Approval Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description 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.

Study Population Description Premenopausal women with heavy menstrual bleeding due to benign causes for whom childbearing was complete.

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.

Data Collection 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.

Follow-up Visits and Length of Follow-up 36 months (3 years)
Interim or Final Data Summary
Interim Safety Information 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.
Actual Number of Patients Enrolled Of 242 intent to treat (ITT) subjects in the pivotal study, 230 were available for post approval study (PAS).
Actual Number of Sites Enrolled 11
Patient Follow-up Rate At 24 months, 210 subjects completed follow-up. The follow-up rate is 86.7% of pivotal ITT subjects (210/242) and 91.3% of PAS subjects (210/230).
Study Strengths & Weaknesses The study progress is consistent with the protocol.

CLARITY Clinical Post-Approval Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 09/26/2019 09/24/2019 On Time
one year report 03/27/2020 03/25/2020 On Time
18 month report 09/25/2020    
two year report 03/27/2021    
three year report 03/27/2022    
four year report 03/27/2023    

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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