EPC Performance Investigation for StereoElectroEncephaloGraphy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

74 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-29

Study Completion Date

2024-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Epilepsy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Depth Coagulation Electrode

SEEG and thermocoagulation

Intervention Type DEVICE

Eligibility Criteria

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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:

* 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

Minimum Eligible Age

18 Months

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No