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| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
P100026 / PAS002 |
| Date Original Protocol Accepted |
11/14/2013
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| Date Current Protocol Accepted |
09/28/2020
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| Study Name |
New Enrollment - All Comers
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| Device Name |
NEUROPACE RNS SYSTEM
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Objective Performance Criterion
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| Analysis Type |
Analytical
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
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 |
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.
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| 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.
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| Key Study Endpoints |
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.
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| 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
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