Status:
RECRUITING
EPC Performance Investigation for StereoElectroEncephaloGraphy
Lead Sponsor:
Alcis
Conditions:
Epilepsy
Eligibility:
All Genders
18-65 years
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...
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 p...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
April 29 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT05223985
Start Date
April 29 2022
End Date
December 30 2024
Last Update
August 5 2024
Active Locations (2)
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1
Centre d'Investigation Clinique : Equipe Timone Adultes CPCET
Marseille, France, 13354
2
Pôle Investigation - Fondation Adolphe de Rothschild
Paris, Île-de-France Region, France, 75019