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| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
P100026 / PAS003 |
| 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 -Performance & Programming
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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 |
Device Subjects Serve as Own Control
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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 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.
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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 |
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.
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| Key Study Endpoints |
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
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| 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.
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