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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Depth Coagulation Electrode | Device | SEEG and thermocoagulation |
| Measure | Description | Time Frame |
|---|---|---|
| Signal quality | percentage of contacts that measured a signal | through study completion, an average of 10 days". |
| Modification of Electroencephalography trace post-coagulation | Modification of Electroencephalography trace post-coagulation | through study completion, an average of 1 hours". |
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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:
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)
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The patient treated by Depth Coagulation Electrode is drug-resistant epilepsies patient.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Sitayeb | Contact | +33 (0)3 81 61 54 16 | ssitayeb@alcis.net | |
| Oualid Chabi | Contact | +33 (0)3 81 61 54 14 | ochabi@alcis.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre d'Investigation Clinique : Equipe Timone Adultes CPCET | Recruiting | Marseille | 13354 | France |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Pôle Investigation - Fondation Adolphe de Rothschild | Recruiting | Paris | Île-de-France Region | 75019 | France |
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