NCT04526418终止不适用
Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients With Epilepsy Involving the Temporal Lobe Region. An Open-label, Prospective, Paired, Comparative Study.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 64
- 试验地点
- 12
- 主要终点
- number of seizures
研究概览
简要总结
The 24/7 EEG™ SubQ system will be compared to simultaneously recorded video-EEG in the Epilepsy Monitoring Unit (gold standard) and to self-reported seizure log books throughout 12 weeks of outpatient EEG recording.
The present study is a 12-week open-label, prospective study with a paired, comparative design for pivotal evaluation of the safety and effectiveness of the 24/7 EEGTM SubQ system in subjects with epilepsy involving the temporal lobe region .
2-5 sites in Europe Up to 10 sites in US
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 18-75 years old.
- •Semiology of seizures compatible with temporal lobe involvement.
- •Paraclinical findings supporting temporal seizure involvement. Such proof may consist of: - previous EEG recording interpreted as compatible with temporal involvement OR - radiological findings demonstrating pathology in the temporal area (CT, MRI, FDG-PET or SPECT).
- •Uncontrolled epileptic seizures.
- •Subject has planned clinical EMU admission with an admission goal including capturing epileptic seizures, within 12 weeks after the date of UNEEG™ SubQ implant.
- •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
- •Subject has a condition that places him/her at a high at high risk of surgical complications, such as an active systemic infection or a hemorrhagic disease.
- •Subject receives frequent (more than 2 days per week) treatment with drugs of the following types:
- •antiplatelets
- •anticoagulants
- •chemotherapeutics
- •non-steroid anti-inflammatory drugs (NSAID)
- •Subject has skeletal deformities or damage at the proposed implantation site to an extent that impedes correct electrode placement.
- •Subject is involved in therapies with other active implantable devices that deliver electrical energy above the clavicular area, such as implantable brain stimulation, external/transcranial brain stimulation, vagus nerve stimulator (VNS) and cochlear implant(s).
- •Subject is pregnant
- •Subject has contraindicated profession or hobby
- •Subject is scheduled to undergo contraindicated treatments/investigations
- •Infection at the implant site
- •Subject has contraindication to the use of anesthetic used for in/ex plantation.
- •Subject is unable to use/operate the device system
- •Subject has abnormal Laboratory findings as follows:
- •Serum creatinine ≥ 3 times upper reference value
- •Alanine aminotransferase (ALT), alkaline phosphatase or bilirubin ≥ 3 times upper reference value
- •Activated Partial Thromboplastin Time (APTT) > 50 seconds
- •thrombocyte count < 50 or >1000 x 109/L
- •International Normalised Ratio (INR) ≥ 1.6
- •Any other clinical or paraclinical finding that in the opinion of the Investigator would interfere with participation in the study or would confound interpretation of the study results.
研究组 & 干预措施
24/7 EEG™ SubQ System
Experimental
To demonstrate the electrographic seizure recording effectiveness of the 24/7 EEG™ SubQ system by comparison to simultaneous inpatient video-EEG data.
干预措施: 24/7 EEG™ SubQ system (Device)
结局指标
主要结局
number of seizures
时间窗: comparasion in EMU for 3-14 days period, where patients are hospitalized.
numbers of seizures as detected in EEG data from SubQ to be compared with number of seizures detected in golden standard (video EEG).
次要结局
- adverse event(2 years)
研究者
研究点 (12)
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