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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 - All Comers


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General
Application Number P100026 / PAS002
Current Plan Approved 06/30/2015
Study Name OSB Lead-New Enrollment - All Comers
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
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.



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.



The primary effectiveness objective will be to estimate the median percent reduction in 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 controlled clinical study (51.3%).



The secondary objective will be to characterize observed battery longevity overall and in relation to total stimulation time and stimulation programming at 5 years.



Additional objectives will be to describe the demographic and clinical characteristics of treated patients, additional procedures including explants and re-implants (reasons, associated complications, and resolution), responder rate,

antiepileptic drug (AED) use, discontinuations, and autopsy data.



Design

An All-comer, 5-year, non-randomized open-label prospective observational study in newly implanted patients treated with the RNS System.

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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 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 onjective (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: Severe adverse event rate; Secondary Safety Endpoints: Seizure worsening

Primary effectiveness endpoint: Median percent reduction in seizures

Additional endpoint: Neurostimulator batter longevity patients characteristics, all-cause mortality, antiepileptic drug (AED) use, subject disposition, RNS system explant/revision, SUDEP rate, responder rate, seizure frequency.

Follow-up Visits and Length of Follow-up Enrollment plan: 2 patients every other month after the first site is enrolled, 12 patients per month after all sites are enrolled.



The study consists of: (a) pre-implant criteria

Informed consent process

Review medical/seizure history

(b) initial implant,

Perform examination

Review medications

Review seizure data

Administer Columbia suicide severity rating scale (C-SSRS)

Review adverse events

Perform surgery activities

and (c) post-implant follow-up.

Complete implant registration form

Distribute Magnet/Remote Monitor

Manage Neurostimulator

Up to 5 years


OSB Lead-New Enrollment - All Comers Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 05/15/2014 05/07/2014 On Time
one year report 11/14/2014 11/12/2014 On Time
18 month report 05/15/2015 05/07/2015 On Time
two year report 11/14/2015 10/21/2015 On Time
30 month report 05/14/2016 05/13/2016 On Time
three year report 11/13/2016 11/08/2016 On Time
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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