Post-Approval Studies (PAS) Database

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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Coflex Actual Practice PAS

General
Study Status	Redesigned/Replaced Study
Application Number / Requirement Number	P110008 / PAS002
Date Original Protocol Accepted	10/17/2012
Date Current Protocol Accepted	04/23/2013
Study Name	Coflex Actual Practice PAS
Device Name	COFLEX® INTERLAMINAR TECHNOLOGY
Clinical Trial Number(s)	NCT00534235
General Study Protocol Parameters
Study Design	Randomized Clinical Trial
Data Source	New Data Collection
Comparison Group	Concurrent Control
Analysis Type	Analytical
Study Population	Adult: >21
Detailed Study Protocol Parameters
Study Objectives	Randomized clinical trial
Study Population	The study population is comprised of patients with radiographic confirmation of at least moderate degenerative spinal stenosis with constriction of the central spinal canal of one or two adjacent segments in the region L1 to L5.
Sample Size	The sample size is 230 patients. There will be 115 patients in each group. There will be 115 patients with decompression surgery and without Coflex, and 115 patients with decompression surgery and the Coflex.
Key Study Endpoints	The primary endpoint is improvement of Oswestry Low Back Pain Disability Index (ODI) after 24 months compared to control group. Secondary endpoints encompass: -Superior improvement of the Visual Analog Scale (VAS) for low back pain (on the 100 mm scale) within 24 months compared to control, group. -Leg pain (Measurement via a 100 mm VAS) -Zurich Claudication Questionnaire (ZCQ). This is a self rating questionnaire designed to assess symptom severity, physical functional status and patient satisfaction -Assessment of significant migration of the implant or the complete expulsion (significant is defined > 5 mm) -Neurological status (assessment of the maintenance of the improvement after surgery throughout the study duration) - Walking distance test on a treadmill (assessment of improvement in walking distance)
Follow-up Visits and Length of Follow-up	Patients will be followed for 2 years. Patients will be evaluated pre-operatively, and at 3, 12 and 24 postoperative months.

Coflex Actual Practice PAS Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
six month report	04/17/2013	07/05/2013	Overdue/Received
one year report	12/01/2013	02/14/2014	Overdue/Received
18 month report	04/17/2014	06/13/2014	Overdue/Received
two year report	10/17/2014	11/28/2014	Overdue/Received

Contact Us

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

Additional Resources

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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background