NCT06205160Recruiting
Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery. ( EpiGrid )
The EpiGrid Study Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery
Source: ClinicalTrials.gov · Last updated 10 Dec 2025
Brief summary (registry, in English)
The objective of this prospective interventional monocentric clinical investigation is to evaluate the feasibility and performance of the flexible high-density SOFT ECoG electrode grids, manufactured by Neurosoft Bioelectronics SA (test device; TD), in comparison to regular high-density electrode grids (ADTech, CE-marked) (control device; CD) routinely used at the investigation site during epilepsy surgery. Subjects will undergo ≥ 2 additional intracranial recordings pre- and post-resection with the TD next to the standard recordings with the CD during ECoG-tailored epilepsy surgery.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 19 Dec 2023
- Start date
- 1 Jan 2025
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Neurosoft Bioelectronics SA
- Diseases
- Epilepsy
- NCT number
- NCT06205160
What you commit to
- Study type: Interventional
- Planned participants: 12
- From 1 Jan 2025 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned ioECoG recordings during fully awake surgery and/or functional recordings
- Active participation in another investigational device study
Other illness
- Use of anticoagulants that cannot be discontinued during the perioperative period, or a factor XIII deficiency or any other haematological disease
- Any other condition that in the opinion of the investigator may adversely affect the safety of the subject or would limit the subject's ability to complete the study.
Other
- Occipital lesion
- Surgeries involving a primary mesial temporal lesion, a disconnection, or hemispherectomy.
- Insufficient understanding of Dutch language.
Who the study is looking for
- Age ≥18 years at the time of enrolment
- Lesional epilepsy (incl. secondary mesial temporal sclerosis) that is considered a candidate for intra-operative high-density grid recordings (incl. patients who underwent sEEG preceding resective surgery)
- Provided informed consent for study participation by the subject
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Center (UMC) Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.