ACTRN12619001587190进行中（未招募）未知
A prospective study to assess the safety of a sub-scalp monitoring device for the recording of brain electrical activity associated with the occurrence of epileptic seizures
Epi-Minder Pty Ltd0 个研究点目标入组 26 人开始时间: 2019年11月19日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 26
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
- Non-randomised trial
- 主要目的
- Diagnosis
- 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. Subject is aged between 18 and 75.
- •2. Subject speaks and reads English.
- •3. Established clinical diagnosis of focal or generalised epilepsy as defined by the ILAE (International League Against Epilepsy) criteria.
- •4. Subject and/or caregiver reports a minimum of two clinically identifiable epileptic events per month.
- •5. Subject can reasonably be expected to maintain a seizure diary and seizure monitoring device alone, or with the assistance of a competent individual.
- •6. Subject able to complete regular study visits and telephone appointments in accordance with the study protocol requirements.
- •7. A female subject must have a negative pregnancy test within two weeks prior to implant, and, if sexually active, must be using a reliable form of birth control, be surgically sterile, or be at least two years post-menopausal. Undertake serum pregnancy test at enrolment. If the negative serum pregnancy test result exceeds the two-week limit, then a negative result from a urine pregnancy kit within two weeks of implant is needed.
排除标准
- •1. Subjects with significant progressive disorders or unstable medical conditions requiring acute intervention.
- •2. Active Vagus Nerve Stimulation (VNS), Deep Brain Stimulation (DBS), Responsive Neurostimulator System (RNS) or other neurostimulation device implanted for epilepsy or other conditions (e.g. cochlear implants).
- •3. Epilepsy surgery within 6 months prior to enrolment
- •6. A serious psychiatric disorder including unstable depression or where changes in pharmacotherapy are needed or anticipated during the study.
- •7. Subjects ineligible for device implantation surgery.
- •8. Subjects anticipated to have or with a high likelihood to have the following contraindicated treatments during the study: Magnetic Resonance Imaging (MRI), Electro-Convulsive Therapy (ECT), lithotripsy and diathermy.
研究者
相似试验
已完成
不适用
A prospective study to evaluate the safety and performance of a shape memory polymer foam embolization device for arterial or venous embolization of the peripheral vasculature system.arterial or venous condition requiring embolizationCardiovascular - Diseases of the vasculature and circulation including the lymphatic systemACTRN12617000906358Shape Memory Medical Inc11
招募中
3 期
A prospective observational study on the safety and efficacy of cryobiopsy using an ultrathin cryoprobe and a therapeutic bronchoscope to evaluate endobronchial lesions in patients under conscious sedatioEndotracheal or endobronchial lesionsJPRN-UMIN000050606ational Hospital Organization Nagoya Medical Center30
已完成
不适用
Prospective Study regarding the Safety of a Periprocedual Anticoagulation Regimen with Direct Oral Anticoagulant (DOAC) Other than Dabigatran in the Patients Undergoing Catheter Ablation for Paroxysmal or Persistent Atrial Fibrillation.paroxysmal or persistent atrial fibrillationJPRN-UMIN000028892Shonankamakura General Hospital Department of Cardiology121
已完成
不适用
Study to Evaluate the Safety and Efficacy of Levetiracetam in Comparison To Magnesium Sulphate in the Management of Severe Pre â?? EclampsiaCTRI/2020/02/023194BLDE Deemed to be University30
招募中
不适用
An observational study to investigate the safety and efficacy of niraparib for Japanese patients with recurrent ovarian cancer: maintenance therapy for platinum-sensitive recurrent treatment and monotherapy for late-line treatmentOvarian cancer, fallopian tube cancer, primary peritoneal cancerJPRN-UMIN000046970Japanese Gynecologic Oncology Group180