EPC Performance Investigation for StereoElectroEncephaloGraphy
Recruiting · NCT05223985 · Observational (researchers observe without assigning treatment) · Lead sponsor: Alcis
View the official record on ClinicalTrials.gov →Interventions studied
Depth Coagulation Electrode
What this trial is about
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.
Who can take part
Age range
18 Months to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 it is running
2 locations listed.
- Centre d'Investigation Clinique : Equipe Timone Adultes CPCET - Marseille, France
- Pôle Investigation - Fondation Adolphe de Rothschild - Paris, Île-de-France Region, France