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NCT Number: NCT05223985

EPC Performance Investigation for StereoElectroEncephaloGraphy

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.

Recruiting

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Key information

Age range

18 month–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pôle Investigation - Fondation Adolphe de Rothschild, Paris, Île-de-France Region, France

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Depth Coagulation Electrode

Device

SEEG and thermocoagulation

Primary outcomes

  1. Signal quality

    Time frame: through study completion, an average of 10 days".

    percentage of contacts that measured a signal

  2. Modification of Electroencephalography trace post-coagulation

    Time frame: through study completion, an average of 1 hours".

    Modification of Electroencephalography trace post-coagulation

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Alcis

Industry

Registry information

Official study title

EPISEEG - EPC Performance Investigation for StereoElectroEncephaloGraphy

Acronym: EPISEEG

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 4, 2022
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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