Actively Recruiting
EPC Performance Investigation for StereoElectroEncephaloGraphy
Led by Alcis · Updated on 2024-08-05
74
Participants Needed
2
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
EPC Performance Investigation for StereoElectroEncephaloGraphy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 months and 65 years
- Diagnosis of drug-resistant and disabling focal epilepsy
- Informed consent obtained from patient or parent/guardian if minor
- Affiliation to social security or recognized foreign regime in France
- For prospective inclusion: Patient planned for SEEG exploration in pre-surgical epilepsy assessment
- For ambispective inclusion: Must have had SEEG with an Alcis device before study start and have prospective follow-up visits with complete information available
You will not qualify if you...
- Unable to comply with study procedures as judged by assessor
- Any medical condition impacting study participation at investigator's discretion
- Pregnant women
- Adults under legal protection measures
- Skull thickness less than 2 mm
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Centre d'Investigation Clinique : Equipe Timone Adultes CPCET
Marseille, France, 13354
Actively Recruiting
2
Pôle Investigation - Fondation Adolphe de Rothschild
Paris, Île-de-France Region, France, 75019
Actively Recruiting
Research Team
S
Sara Sitayeb
CONTACT
O
Oualid Chabi
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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