In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
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.
All premarket subjects
Followup Visits and Length of Followup
Final Study Results
Actual Number of Patients Enrolled
Actual Number of Sites Enrolled
Patient Followup 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 Effectiveness 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 and 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