NCT01450735终止不适用
Evaluation of the MANOS Carpal Tunnel Release System in Patients With Carpal Tunnel Syndrome
Thayer Intellectual Property, Inc.6 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Gather clinical outcome data on the safety and efficacy of the MANOS Carpal Tunnel Release System.
研究概览
简要总结
The MANOS device is a carpal tunnel blade used to perform carpal tunnel release (CTR). CTR is indicated for the treatment of Carpal Tunnel Syndrome when conservative therapy fails. This study is being conducted to evaluate the safety and effectiveness of CTR with the MANOS device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Patient is scheduled to undergo carpal tunnel release surgery.
- •Patient has chronic Carpal Tunnel Syndrome with persistent symptoms despite non-operative treatment, or refusal of non-operative treatment, with one or more of the following: splinting, NSAIDs or corticosteroid injections.
- •Carpal Tunnel Syndrome must be confirmed by positive results of Electromyography (EMG) and Nerve Conduction Velocity (NCV) tests.
- •Patient is a male or non-pregnant, non-lactating female.
- •Patient is 18-75 years of age, inclusive.
- •Female patients of child-bearing potential, including those who have had a tubal ligation, but excluding those who have not experienced a menstrual period for at least two years, must have a negative urine pregnancy test at Screening.
- •Patient must voluntarily provide written, informed consent.
排除标准
- •Patient has a prior or current musculoskeletal or neurologic condition that limits strength, motion, or sensation in the affected hand.
- •Patient has a medical condition that precludes the use of anesthetic required for surgery.
- •Patient has an ipsilateral injury or other conditions affecting hand function.
- •Patient has acute CTS resulting from an injury (e.g., fracture).
- •Patient has had previous CTR surgery on the affected hand.
- •Patient has psychiatric history, head injury or any other condition which, in the Investigator's opinion, would prevent patient from complying with post-operative hand therapy or follow-up visits.
结局指标
主要结局
Gather clinical outcome data on the safety and efficacy of the MANOS Carpal Tunnel Release System.
时间窗: Baseline throughout 12 weeks post-operatively
Clinical outcome data that will be evaluated: * Carpal Tunnel Syndrome Questionnaire (CTSQ) * Scar sensitivity * Hand sensation * Grip and pinch strength * Hand dexterity
次要结局
- Safety information will be evaluated by collecting the type, frequency, severity, device, and procedure-relatedness of adverse events.(Baseline throughout 12 weeks post-operatively)
研究者
研究点 (6)
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