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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-New Enrollment -Performance & Programming


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General
Application Number P100026 / PAS003
Current Plan Approved 06/30/2015
Study Name OSB Lead-New Enrollment -Performance & Programming
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Objectives

The primary safety objective is to characterize the annual serious adverse event (SAE) rate over 5 years in patients treated with the RNS System.

The primary effectiveness objective is to demonstrate the median percent reduction in disabling seizures from baseline (3 months pre-implant) to 3 years in the PAS, and evaluate if this reduction is comparable to the median percent reduction in seizures from baseline to 3 years in the LTT controlled clinical study.

The secondary safety objective is to demonstrate that there is not a worsening in seizures over time in patients treated with the RNS® System beginning at 6 to 12 months post implant and extending to 3 years.

Additional objectives include characterizing, describing, and evaluating:

¿ Patient characteristics

¿ Adverse events of particular relevance

¿ All-cause mortality

¿ Anti-epileptic drug (AED) use

¿ Subject disposition

¿ RNS System explant/revision

¿ Sudden unexpected death in Epilepsy (SUDEP) rate

¿ Median percentage change

¿ Responder rate

¿ Seizure frequency

in sub-populations of subjects treated with the RNS® System.

Programming-related:

The primary safety objective is to demonstrate that there is no difference in safety in the 6-week perioperative period based on the experience of NeuroPace qualified and trained implanting physicians.

The co-primary safety objective is to demonstrate that there is no difference in safety 1 year post implant on the experinece of NeuroPace qualified and trained treating physicians and Comprehensive Epilepsy Centers.

The primary effectiveness objective is to demonstrate that the stimulation programming classes have similar effects on the overall seizure frequency.

The secondary objective is to characterize the effects of the stimulation programming classes on the overall 5 year rate of SAEs and device related non serious AEs.

Design:

A 5 year, non randomized open label prospective observational study in newly implanted patients treated with the RNS system.
Study Population Description The study population will consist of individuals 18 years of age or older with partial onset seizures who have undergone diagnostic testing that localized no more than 2 epileptogenic foci, are refractory to 2 or more antiepileptic medications, and currently have frequent and disabling seizures.
Sample Size Sample size:

Up to 375 subjects may be enrolled from up to 30 sites in order that a minimum of

300 subjects be implanted, with no individual investigational site implanting more than 15 subjects.

Assumptions:

The sample size calculation is based on the endpoint related to the secondary safety objective (seizure worsening) Sample size calculation for a regression model with a log link and including a term for linear slope in the dependent variable indicates that 240 patients will provide over 80% power for the ability to detect a possible slope equivalent to a 20% cumulative increase in seizures over the period from pre‐implant to 30 to 36 months post‐implant. The sample size calculation assumes a linear regression t test of the slope with a one sided alpha of 0.05, and a standard deviation of 0.28 applicable to the term for linear slope. Conservatively assuming approximately 25% of patients do not contribute the full 3 years of data leads to selection of 300 implanted patients as the sample size.

Data Collection Primary Safety Endpoint: SAE rate; Secondary Safety Endpoins: Seizure worsening

Primary effectiveness endpoint: Median percent reduction in seizures

Programming-related endpoints:

Primary Safety Endpoint ¿ Neurosurgeon Experience

Primary Safety Endpoint ¿ Physician Experience

Primary Effectiveness Endpoint ¿ Neurostimulator Programming

Secondary Safety Endpoint ¿ Neurostimulator Programming

Follow-up Visits and Length of Follow-up 5 years

Patients will be followed through 5 years with assessments at 15 days, 1 month, 3 months, 6 months, 9 months, 12 months, and then every 4 months until 60 months upon conclusion of the study.



OSB Lead-New Enrollment -Performance & Programming Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 05/15/2014 05/08/2014 On Time
one year report 11/14/2014 11/10/2014 On Time
18 month report 05/15/2015 05/08/2015 On Time
two year report 11/14/2015 10/19/2015 On Time
three year report 11/13/2016    
four year report 11/13/2017    
five year report 11/13/2018    


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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