EPC Performance Investigation for StereoElectroEncephaloGraphy (EPISEEG)

EPISEEG - 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.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy
• Intervention / Treatment: Device: Depth Coagulation Electrode

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.

• Study Type: Observational
• Enrollment (Estimated): 74

Contacts and Locations

• Study Contact: Name: Sara Sitayeb; Phone Number: +33 (0)3 81 61 54 16; Email: ssitayeb@alcis.net
• Study Contact Backup: Name: Oualid Chabi; Phone Number: +33 (0)3 81 61 54 14; Email: ochabi@alcis.net

Study Locations

• France
  • Marseille, France, 13354
    • Recruiting
    • Centre d'Investigation Clinique : Equipe Timone Adultes CPCET
    • Contact: Romain CARRON; Phone Number: 04 91 38 65 64; Email: Romain.CARRON@ap-hm.fr
    • Contact: Claire DIMIER; Phone Number: 04 91 43 53 73; Email: Claire.DIMIER@ap-hm.fr
  • Ile De France
    • Paris, Ile De France, France, 75019
      • Recruiting
      • Pôle Investigation - Fondation Adolphe de Rothschild
      • Contact: Georg Dorfmuller; Phone Number: 01 48 03 68 17; Email: gdorfmuller@for.paris
      • Contact: Fiona ROCHE; Phone Number: 8054 01 48 03 65 56; Email: froche@for.paris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 61 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

The patient treated by Depth Coagulation Electrode is drug-resistant epilepsies patient.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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".

Collaborators and Investigators

• Sponsor: Alcis

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2022
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: December 23, 2021
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Actual): August 5, 2024
• Last Update Submitted That Met QC Criteria: August 2, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: EPISEEG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No