Investigating the performance of Alcis devices for epilepsy treatment
EPISEEG - EPC Performance Investigation for StereoElectroEncephaloGraphy
This study is testing how well Alcis devices work and their safety for people with drug-resistant focal epilepsy who are undergoing a specific brain procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 74 (estimated) |
| Ages | 18 Months to 65 Years |
| Sex | All |
| Sponsor | Alcis Industry-sponsored |
| Locations | 2 sites (Marseille and 1 other locations) |
| Trial ID | NCT05223985 on ClinicalTrials.gov |
What this trial studies
This multicentre observational study aims to collect data on the safety and performance of Alcis products used in stereo-electroencephalography (SEEG) for patients with drug-resistant focal epilepsy. It will gather preoperative, intraoperative, and follow-up data over a period of one year to assess clinical complications and functional outcomes. The findings will contribute to post-market surveillance and support clinical evaluations and publications regarding the devices' effectiveness in real-world settings.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 18 months to 65 years with drug-resistant and disabling focal epilepsy who are undergoing SEEG exploration as part of their pre-surgical assessment.
Not a fit: Patients who do not have drug-resistant focal epilepsy or those unable to comply with study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of Alcis devices' safety and efficacy, potentially leading to improved treatment options for patients with epilepsy.
How similar studies have performed: Other studies have shown success in evaluating the performance of similar devices in epilepsy treatment, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * To be included, patients must be: * 18 months to 65 years * Patient with drug-resistant and disabling focal epilepsy * Informed and willing to sign an informed consent form approved by EC / For minors: if one of the parents cannot consent within the timeframe provided by the protocol, then only one parent's signature is required * Affiliation to the social security or foreign regime recognized in France * For prospective inclusion: Patient considered for SEEG exploration as part of pre-surgical assessment of epilepsy * For ambispective inclusion: * Must have undergone an SEEG exploration with one ALCIS device before the date of the initiation visit * Follow-up visits (at least 12-month) must be prospective * Must have complete information available for each completed visit (demographics, preoperative information, implantation information, device details) \*. Exclusion Criteria: * • Not able to comply with the study procedures based on the judgment of the assessor (e.g. cannot comprehend study questions, inability to keep scheduled assessment times) * Any medical condition that could impact the study at investigator's discretion (e.g. allergy…) * Pregnant women (contraindication to SEEG exploration) * Adult subject to legal protection measure * Skull thickness inferior at 2 mm
Where this trial is running
Marseille and 1 other locations
- Centre d'Investigation Clinique : Equipe Timone Adultes CPCET — Marseille, France (Recruiting)
- Pôle Investigation - Fondation Adolphe de Rothschild — Paris, Île-de-France Region, France (Recruiting)
Study contacts
- Study coordinator: Sara Sitayeb
- Email: ssitayeb@alcis.net
- Phone: +33 (0)3 81 61 54 16
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.