EPC Performance Investigation for StereoElectroEncephaloGraphy

Epilepsy Clinical Trial

— EPISEEG  

Official title:

EPISEEG - EPC Performance Investigation for StereoElectroEncephaloGraphy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05223985
• Other study ID #: EPISEEG
• Status: Recruiting
• Start date: April 29, 2022
• Est. completion date: February 2024

Study information

• Verified date: January 2023
• Source: Alcis
• Contact: Sara Sitayeb
• Phone: +33 (0)3 81 61 54 16
• Email: ssitayeb[@]alcis.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: February 2024
• Est. primary completion date: December 15, 2023
• Gender: All
• Age group: 18 Months to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Device:
• Depth Coagulation Electrode
SEEG and thermocoagulation

Locations

Country	Name	City	State
France	Centre d'Investigation Clinique : Equipe Timone Adultes CPCET	Marseille
France	Pôle Investigation - Fondation Adolphe de Rothschild	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Alcis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Signal quality	percentage of contacts that measured a signal	through study completion, an average of 10 days".
Primary	Modification of Electroencephalography trace post-coagulation	Modification of Electroencephalography trace post-coagulation	through study completion, an average of 1 hours".