DRKS00025526招募中未知
Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients with Temporal Lobe Epilepsy - ULTRA/U002
EEG Medical A/S0 个研究点目标入组 15 人开始时间: 2021年6月15日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1. Semiology of seizures compatible with temporal lobe involvement
- •2. Paraclinical findings supporting temporal seizure focus. 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).
- •3. Uncontrolled epileptic seizures
- •4. Subject has planned clinical EMU admission with an admission goal, including capturing epileptic seizures, within 12 weeks after the date of UNEEG™ SubQ implantation.
- •5. Subject is willing and able to provide written informed consent.
- •6. Subject is able to complete all study-required procedures, assessments and follow-up.
排除标准
- •1.Subject has a condition that places him/her at a high risk of surgical complications, such as an active systemic infection or a haemorrhagic disease.
- •2.Subject receives frequent (more than 2 days per week) treatment with the following types of drugs:
- •a.anti-platelets
- •b.anticoagulants
- •c.chemotherapeutics
- •d.non-steroid anti-inflammatory drugs (NSAID)
- •3.Subject has skeletal deformities or damage at the proposed implantation site to the extent that it impedes correct electrode placement.
- •4.Subject has an active deep brain stimulation device.
- •5.Subject has or is exposed to a medical device that delivers electrical energy into the area around the implant.
- •6.Subject has a cochlear implant(s).
- •7.Subject is pregnant, intends to become pregnant, is breastfeeding, or is a female of childbearing potential not using an adequate contraceptive method during the study period. Adequate methods of birth control include stable hormonal contraception, intrauterine device, double barrier (e.g. condom with spermicide), tubal ligation, sole vasectomized partner, or consistent abstinence.
- •8.Subject has a profession or hobby that includes activity imposing extreme variations in pressure , e.g. diving or parachuting. Diving/snorkelling is allowed to a depth of 5 meters.
- •9.Subject has a profession or hobby that includes activity imposing an unacceptable risk of trauma to the device or implant site, e.g. martial arts or boxing.
- •10.Subject is scheduled to undergo any of the following treatments within 4 months of enrolment:
- •a.MRI scan (it is not known if the UNEEG™ SubQ implant is MRI safe)
- •b.Therapeutic ionizing radiation treatment close to the implantation site, e.g. radiation therapy for cancer.
- •c.Therapeutic ultrasound treatment close to the implantation site.
- •d.Electrical current induced close to the implant (e.g. electro knife, electroconvulsive therapy).
- •11.Subject operates an MRI scanner.
- •12.Subject has an infection at the implantation site.
- •13.Subject has a contraindication to the use of local anaesthetic drugs used during implantation- and explantation.
- •14.Subject is unable, or does not have the necessary assistance, to properly operate the device system.
- •15.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.
研究者
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