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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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OSB Lead-F/U Axium Neurostimulator System (FANS)


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General
Study Status Progress Adequate
Application Number P150004 / PAS001
Date Current Protocol Accepted 08/25/2017
Study Name OSB Lead-F/U Axium Neurostimulator System (FANS)
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The FANS PAS is a prospective, multicenter, single arm, observational post-approval study to be conducted at ~40 centers in the United States in order to demonstrate continued safety and effectiveness of the Axium Neurostimulator System or the Proclaim DRG Neurostimulator System. The primary objective of the FANS PAS is to demonstrate that the proportion of serious adverse events (SAEs) at 12 months for subjects who receive a permanent implant is lower than a pre-specified performance goal. Secondary objectives of the FANS PAS are to evaluate change in overall pain intensity, change in physical function and change in quality of life over the study period.
Study Population Description Inclusion Criteria:

Male or female between the ages of 22 and 75 years.

Moderate to severe chronic intractable pain of the lower limbs resulting from Complex Regional Pain Syndrome (CRPS) types I or II.

Baseline VAS score of > 60 mm for overall pain at the time of the baseline assessment.

Willing and able to comply with the study requirements.

Able to provide written informed consent.



Exclusion criteria:

Active implantable medical device including but not limited to cardiac pacemakers and cardiac defibrillators.

Currently involved in medically-related litigation, including workers compensation.

Life expectancy of less than one year.

Pregnant or of child bearing potential and not using adequate contraception as determined by the investigator.

Has, or plans to have, a spinal cord stimulation system or infusion pump system implanted.

Has, or plans to have, a peripheral nerve stimulation system or peripheral nerve field stimulation system implanted.

Is considered to be a poor surgical or study candidate.

Sample Size Axium Neurostimulator System: A maximum of 37 patients will receive a permanent implant and will be followed-up for 12 months.



Proclaim DRG Neurostimulator System: The sample size required to reject the hypothesis for the primary endpoint at the 5% significance level with 80% power assuming a 12-month SAE rate of 10.5% is 287 subjects.



Assuming attrition rate of 15% from trial to permanent implant and attrition rate of 10% from permanent implant to 12-month follow- up, a total of 376 subjects will be implanted with a trial.

The target number of subjects for permanent neurostimulator system implants is 319 and the target number of subjects for the primary endpoint analysis is 287.



Data Collection Main Endpoint:

12-month SAE rate for permanent implants

Secondary Endpoints:

Percent change for overall pain intensity measured using the Visual Analog Scale (VAS)

Change for physical function measured using the PROMIS-29 Profile Physical Function domain

Change for quality of life measured using the PROMIS Global Health Scale





Follow-up Visits and Length of Follow-up 12 months


OSB Lead-F/U Axium Neurostimulator System (FANS) Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 08/11/2016 08/11/2016 On Time
one year report 02/10/2017 02/16/2017 Overdue/Received
18 month report 08/11/2017 08/15/2017 Overdue/Received
two year report 02/10/2018    
three year report 02/10/2019    
four year report 02/10/2020    
five year report 02/09/2021    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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