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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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Study Status Terminated
Application Number P040028 / PAS001
Date Current Protocol Accepted 03/16/2006
Study Name OSB Lead-LUMA
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Adolescent: 13-18 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description 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.
Follow-up Visits and Length of Follow-up There is no follow up in this study. Subject complete participation within 20 minutes.

OSB Lead-LUMA Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 09/14/2006 09/25/2006 Overdue/Received
1 year report 03/16/2007 03/21/2007 Overdue/Received
6 month report (Spectra) 09/15/2008 09/12/2008 On Time
1 year report (Spectra) 03/17/2009 03/03/2009 On Time
2 year report (Spectra) 06/21/2010 06/22/2010 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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