NCT00942474撤回不适用
A Prospective, Non Randomized, Single-center, Non-blinded Feasibility Study Examining the Use of a Nerve Access Tool
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Electromyography Response
研究概览
简要总结
The purpose of this study is to assess the ability of the nerve access tool to facilitate nerve stimulation lead placement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is equal to or greater than 18 years of age
- •Subject has a diagnosis of cystocele with planned surgical repair
- •Subject has no known deficit of the nerve
- •Subject is willing and able to provide written informed consent and HIPAA authorization to participate by signing the Informed Consent/Health Insurance Portability and Accountability Act Form after a full explanation of the nature and purpose of this study
- •Subject is willing and able to comply with the study protocol
排除标准
- •Subject has known neurological abnormalities of the nerve
- •Subject has a known allergy to the tool or neurostimulation lead components
- •Subject is pregnant or lactating
结局指标
主要结局
Electromyography Response
时间窗: Implant
次要结局
未报告次要终点
研究者
相似试验
已完成
早期 1 期
Selective Nerve Stimulation (SNS) Pilot StudyHealthyPainNCT01259271Codman & Shurtleff60
已完成
不适用
Clinical Trial to Study a Non-invasive Neurostimulation Device on Urgency (Urinary) Incontinence Overactive Bladder (OAB)Overactive BladderNCT01125722Ethicon Endo-Surgery74
已完成
不适用
Safety of Noninvasive Electrical Stimulation of Acupuncture Points (NESAP) in InfantsPainNCT01495286University of Arkansas30
终止
不适用
SubQStim: A Post-market Study of Subcutaneous Nerve Stimulation in Failed Back Surgery Syndrome (FBSS) PatientsFailed Back Surgery SyndromeNCT01711619MedtronicNeuro162
尚未招募
不适用
Peripheral Nerve Stimulation Therapy for Atrial FibrillationAtrial FibrillationNCT05653583Cala Health, Inc.30