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.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
This study is a multi-center single-arm internally controlled trial that will enroll approximately 950 subjects
at up to 9 clinical study sites to assess LUMA's ability to detect significantly more subjects with CIN 2/3+ compared to colposcopy alone
Study Population Description
Study population is as per device indication. This device is indicated for use as an
adjunct to colposcopy for the identification of high-grade disease (CIN 2, 3+) in women referred to colposcopy with a Pap test result of atypical squamnous cells (ASC), low-grade squamous intraepithelial lesion (LSIL), highgrade squamous intraepithelial lesion or cancer (HSIL+). PAS required oversampling of women younger than 21 years.
Sample Size
800 evaluable women at 9 sites
Data Collection
Each patient will be evaluated with colposcopy first and then with LUMA. Primary object is
to assess the relationship between subject age and the performance of LUMA as adjunct to
colposcopy for detection of CIN 2,3+. Secondary objective will be to assess relationship between colposcopists' experience and performance of LUMA. Method for data collection included physician visit for colposcopy and subsequent biopsy.
Followup Visits and Length of Followup
There is no follow up in this study. Subject complete participation within 20 minutes.
