EPC Performance Investigation for StereoElectroEncephaloGraphy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Depth Coagulation Electrode.
- Who it may be relevant to
- Registry conditions: Epilepsy. Basic parameters: 18 months — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
EPISEEG - EPC Performance Investigation for StereoElectroEncephaloGraphy
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.
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 peer-reviewed publications on products performance and safety.
Interventions
- Device Depth Coagulation Electrode
SEEG and thermocoagulation
Primary outcome measures
- Signal quality [Time frame: through study completion, an average of 10 days".]
- Modification of Electroencephalography trace post-coagulation [Time frame: through study completion, an average of 1 hours".]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Other
Study locations
France · 2 centers
- Centre d'Investigation Clinique : Equipe Timone Adultes CPCET — Marseille
- Pôle Investigation - Fondation Adolphe de Rothschild — Paris
Identifiers
NCT: NCT05223985 · EPISEEG