EPISEEG - EPC Performance Investigation for StereoElectroEncephaloGraphy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Alcis
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Signal quality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Months 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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) *.
排除标准
- •• 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
结局指标
主要结局
Signal quality
时间窗: through study completion, an average of 10 days".
percentage of contacts that measured a signal
Modification of Electroencephalography trace post-coagulation
时间窗: through study completion, an average of 1 hours".
Modification of Electroencephalography trace post-coagulation
次要结局
未报告次要终点