Epilepsy
Conditions
Brief summary
The objective of this multicentre study is to collect preoperative, intra operative, early, short, intermediate and mid-term(one years) on the related clinical complications and functional outcomes of market-approved Alcis products to demonstrate safety and performance of these devices in a real-world setting.
Detailed description
Outcome data collected from this study will provide the basis for Post-Market Surveillance (PMS) reporting, Clinical Study Report (CSR), Clinical Evaluation Report (CER) on Alcis devices and support peer-reviewed publications on products performance and safety.
Interventions
DEVICEDepth Coagulation Electrode
SEEG and thermocoagulation
Sponsors
Alcis
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Months to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Signal quality | through study completion, an average of 10 days. | percentage of contacts that measured a signal |
| Modification of Electroencephalography trace post-coagulation | through study completion, an average of 1 hours. | Modification of Electroencephalography trace post-coagulation |
Countries
France
Contacts
Primary ContactSara Sitayeb
Backup ContactOualid Chabi
Outcome results
None listed