Overview
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.
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.
Eligibility
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