EPC Performance Investigation for StereoElectroEncephaloGraphy
EPISEEG
EPISEEG - EPC Performance Investigation for StereoElectroEncephaloGraphy
1 other identifier
observational
74
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2022
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2021
CompletedFirst Posted
Study publicly available on registry
February 4, 2022
CompletedStudy Start
First participant enrolled
April 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedAugust 5, 2024
August 1, 2024
2.7 years
December 23, 2021
August 2, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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".
Interventions
SEEG and thermocoagulation
Eligibility Criteria
The patient treated by Depth Coagulation Electrode is drug-resistant epilepsies patient.
You may qualify if:
- To be included, patients must be:
- 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
- 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) \*.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcislead
Study Sites (2)
Centre d'Investigation Clinique : Equipe Timone Adultes CPCET
Marseille, 13354, France
Pôle Investigation - Fondation Adolphe de Rothschild
Paris, Île-de-France Region, 75019, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2021
First Posted
February 4, 2022
Study Start
April 29, 2022
Primary Completion
December 30, 2024
Study Completion
December 30, 2024
Last Updated
August 5, 2024
Record last verified: 2024-08