Trials / Recruiting
RecruitingNCT05223985
EPC Performance Investigation for StereoElectroEncephaloGraphy
EPISEEG - EPC Performance Investigation for StereoElectroEncephaloGraphy
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 74 (estimated)
- Sponsor
- Alcis · Industry
- Sex
- All
- Age
- 18 Months – 65 Years
- Healthy volunteers
- —
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Depth Coagulation Electrode | SEEG and thermocoagulation |
Timeline
- Start date
- 2022-04-29
- Primary completion
- 2024-12-30
- Completion
- 2024-12-30
- First posted
- 2022-02-04
- Last updated
- 2024-08-05
Locations
2 sites across 1 country: France
Source: ClinicalTrials.gov record NCT05223985. Inclusion in this directory is not an endorsement.