EpilepsyEPISEEGNCT05223985
EPC Performance Investigation for StereoElectroEncephaloGraphy
An observational study of Epilepsy, run by Alcis at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 months to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Depth Coagulation Electrode
- Type of treatment
- Medical device
- How many people
- 74 participants
- Where
- 2 sitesFrance
- Study dates
- 29 Apr 2022to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 65 years
- All sexes
- Child, Adult, Older adult
Study population: The patient treated by Depth Coagulation Electrode is drug-resistant epilepsies patient.
Who may be able to join
- 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
Show all 10Show fewer
- 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) *.
Who cannot join
- • 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
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Centre d'Investigation Clinique : Equipe Timone Adultes CPCET
Marseille, 13354
Romain CARRON, 04 91 38 65 64, Romain.CARRON@ap-hm.fr
Claire DIMIER, 04 91 43 53 73, Claire.DIMIER@ap-hm.fr
- Recruiting
Pôle Investigation - Fondation Adolphe de Rothschild
Paris, Île-de-France Region, 75019
Georg Dorfmuller, 01 48 03 68 17, gdorfmuller@for.paris
Fiona ROCHE, 01 48 03 65 56 ext. 8054, froche@for.paris
About this study
Official title: 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.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- Depth Coagulation Electrode
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depth Coagulation ElectrodeDevice
SEEG and thermocoagulation
What is being measured
The primary outcome is the main question the study is designed to answer.
Signal quality
percentage of contacts that measured a signal
Measured: through study completion, an average of 10 days".
Modification of Electroencephalography trace post-coagulation
Modification of Electroencephalography trace post-coagulation
Measured: through study completion, an average of 1 hours".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start29 Apr 2022
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alcis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223985
- Sponsor's protocol ID
- EPISEEG
- Acronym
- EPISEEG
- Status last verified
- Aug 2024
- First submitted
- 23 Dec 2021
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EPISEEG - EPC Performance Investigation for StereoElectroEncephaloGraphy
- ClinicalTrials.gov ID
- NCT05223985
- Acronym / sponsor ID
- EPISEEG / EPISEEG
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- AlcisIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 months to 65 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The patient treated by Depth Coagulation Electrode is drug-resistant epilepsies patient.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- • 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Depth Coagulation ElectrodeSEEG and thermocoagulation | Device | – |
Primary outcome
Signal quality
Time frame: through study completion, an average of 10 days".
percentage of contacts that measured a signal
Modification of Electroencephalography trace post-coagulation
Time frame: through study completion, an average of 1 hours".
Modification of Electroencephalography trace post-coagulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Alcis at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Sitayeb (+33 (0)3 81 61 54 16, ssitayeb@alcis.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signal quality (time frame: through study completion, an average of 10 days".). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.