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NCT04796597

Early Feasibility Study on Epios Leads

Completed NA Last updated 14 November 2023
What this trial tests

NA trial testing Subcutaneous implantation of Epios sub-scalp leads in Epilepsy in 10 participants. Completed in 2 November 2023.

Timeline
23 March 2021
Primary endpoint
7 July 2023
2 November 2023

Quick facts

Lead sponsorWyss Center for Bio and Neuroengineering
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsequential
Maskingnone
Primary purposedevice feasibility
Enrollment10
Start date23 March 2021
Primary completion7 July 2023
Estimated completion2 November 2023
Sites1 location across Switzerland

Drugs / interventions tested

Conditions studied

Sponsor

Wyss Center for Bio and Neuroengineering

Who can join

18 and older, any sex, with Epilepsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The Epios early feasibility study aims to explore the uses of novel sub-scalp lead devices in the detection of epileptic seizures. Epios leads are inserted subcutaneously through dedicated tunneling toolkits and have been designed for continuous EEG recording in inpatients. This clinical investigation is part of a stepwise program to validate the entire Epios system and it starts with the validation of the Epios leads alone in this two steps study.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Feasibility, Safety, and Performance of Full-Head Subscalp EEG Using Minimally Invasive Electrode Implantation.
    van Maren E, Alnes SL, Ramos da Cruz J, Sobolewski A, et al · · 2024 · cited 7× · PMID 38843489 · DOI 10.1212/wnl.0000000000209428
  2. Novel subscalp and intracranial devices to wirelessly record and analyze continuous EEG in unsedated, behaving dogs in their natural environments: A new paradigm in canine epilepsy research.
    Löscher W, Worrell GA. · · 2022 · cited 4× · PMID 36337210 · DOI 10.3389/fvets.2022.1014269

Verify or expand the search:

Other recruiting trials for Epilepsy

Currently open trials in the same condition.

Other Wyss Center for Bio and Neuroengineering trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04796597.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing