Wireless Ultra Long-Term EEG Recordings in Epilepsy - A Prospective Long-term Clinical Evaluation Using the UNEEG EpiSight Solution
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Epilepsy
- 发起方
- UNEEG Medical A/S
- 入组人数
- 19
- 试验地点
- 5
- 主要终点
- Usage of UNEEG EpiSight Recorder
- 状态
- 进行中（未招募）
- 最后更新
- 5个月前
概览
简要总结
The present study is a 13 months pre-market open-label, prospective study for confirmation of continuous performance and safety of UNEEG EpiSight solution in subjects with uncontrolled epilepsy (indicated for EEG monitoring with the Implant) in which seizures are detectable in an area of the Implant. The surgical procedure, device satisfaction, and effectiveness of the UNEEG EpiSight solution will also be evaluated during the clinical investigation.
详细描述
The study is a multi-center study with 2-5 European sites in 2-4 countries. Each site will enrol up to 10 subjects, but total enrolment will not exceed 22 to reach 19 completers of 40 days of recording. The total recruitment period is expected to be 6 months and the total study duration is expected to be approximate 22 months (first subject first visit to last subject out).
研究者
入排标准
入选标准
- •Patients with uncontrolled epilepsy in which seizures are detectable in an area covered by the implant
- •Adults (above 18 years)
- •Is willing and able to use the UNEEG EpiSight solution day and night for the duration of the study
- •Subject is willing and able to provide written informed consent
- •Subject is able to complete all study-required procedures, assessments and follow-up
排除标准
- •Vulnerable subjects, including severe cognitive impairment precluding informed consent
- •Cannot or do not have the necessary assistance, to properly operate the system
- •High risk of surgical complications, such as active systemic infection and haemorrhagic disease
- •Involved in therapies with medical devices that deliver electrical energy into the area around the implant, such as cochlear implant(s), implantable brain stimulation and external/transcranial brain stimulation
- •Contraindications to the local anaesthetic used during implantation and explantation
结局指标
主要结局
Usage of UNEEG EpiSight Recorder
时间窗: Throughout the run of the investigation (enrollment per subject is up to 12 months)
Number of recording hours by UNEEG EpiSight Recorder per day (24 hours) after 40 days recording
次要结局
- Device deficiencies(Throughout the run of the investigation (enrollment per subject is up to 12 months))
- Adverse events(Throughout the run of the investigation (enrollment per subject is up to 12 months))