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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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Her Option PAS

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Study Status Completed
Application Number P000032 S028/ PAS001
Date Current Protocol Accepted 03/27/2009
Study Name Her Option PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective study to continue follow-up of the premarket cohort. As per approval order, the results of the 2 and 3-year follow-up of the study subjects will be provided.
Study Population Description This device is a closed-cycle cryosurgical device intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete. The study population is the subjects that were treated premarket.
Sample Size All premarket subjects
Follow-up Visits and Length of Follow-up 3 years
Interim or Final Data Summary
Interim Safety Information We have not received any reports.
Actual Number of Patients Enrolled 106 women
Actual Number of Sites Enrolled 7
Patient Follow-up Rate At the end of the three year follow-up 51 participants were followed out of 82 treated (62.2%)
Final Safety Findings

Of the 82 subjects treated, 54 subjects (65.9%) were free of any treatment-related complications or side-effects. Only 2 (2.4%) subjects experienced serious adverse events related to study treatment. According to the Sponsor, there were no serious unanticipated adverse events within the study population. The Sponsor reported a reduction of pain/cramping and PMS symptoms following treatment , with 10 and 14 subjects reporting moderate to severe symptoms immediately after the intervention and after 12 months respectively. According to Sponsor incident events of bleeding through onto clothing was reported by 95% of subjects at the baseline assessment. At the 12 month visit, only 8% of subjects reported negative impact on quality of life, and bleed-through incidences were reduced to 23% of subjects

Final Effect Findings

Long term success rates were calculated for the 2-year and 3-year visits and demonstrate a success rate of 56.1% and 54.9% of subjects treated respectively. A percent reduction in menstrual levels from baseline was achieved in 89.4%, 90.9%, and 92.1% of participants after each of the three years of follow-up respectively.

Study Strengths & Weaknesses This multicenter study was well planned and conducted to evaluate the effectiveness of this surgical device to treat menorrhagia due to benign causes in women for whom childbearing is complete. The study was conducted at seven sites by gynecology specialists with experience in the device and who were familiar with clinical research. As with any other study, there are limitations that need to be pointed out to have a better understanding of the results. Data from 9 censored patients, due to lack of effectiveness of the device, are excluded from the analysis. If these participants were included in the calculation, the effectiveness is estimated at 72.9% (35/48).
Recommendations for Labeling Changes Labeling should be updated with the results of the study at all evaluation follow-up times in the context of physician and patient.

Her Option PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
Final Report 03/27/2010 01/28/2011 Overdue/Received

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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