Informations générales (source: ClinicalTrials.gov)
EPISEEG - EPC Performance Investigation for StereoElectroEncephaloGraphy (EPISEEG)
Observational
Alcis (Voir sur ClinicalTrials)
avril 2022
décembre 2024
06 août 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FONDATION A. DE ROTHSCHILD | Georg Dorfmuller | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre d'Investigation Clinique : Equipe Timone Adultes CPCET - 13354 - Marseille - France | Romain CARRON | Contact (sur clinicalTrials) | |||
Critères
Tous
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) *.
- 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) *.
- • 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