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Active Not RecruitingNCT03900468

Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval Study (EPAS)

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
140 (estimated)
Sponsor
MedtronicNeuro · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this post-approval study is to further evaluate the long-term safety and effectiveness of Medtronic DBS therapy for epilepsy on seizure reduction in newly implanted participants through 3 years of follow-up.

Conditions

Interventions

TypeNameDescription
DEVICEActiva™ PC and Percept™ PC Neurostimulation SystemsImplanted DBS system consisting of a Neurostimulator, Leads, Extensions, and potential accessories including Burr Hole Devices, Clinician Tablet, Clinician Programmer Therapy Application Software, Clinician Programmer Communicator, Patient Programmer

Timeline

Start date
2020-03-05
Primary completion
2025-10-15
Completion
2026-03-27
First posted
2019-04-03
Last updated
2026-02-11

Locations

13 sites across 2 countries: United States, Czechia

Regulatory

Source: ClinicalTrials.gov record NCT03900468. Inclusion in this directory is not an endorsement.

Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval Study (EPAS) (NCT03900468) · Clinical Trials Directory