NCT01014494Unknown不适用
A Randomized, Double Blind Clinical Investigation to Evaluate the Safety, Tolerability, and Preliminary Performance of Adaprev™ in Improving Recovery of Tendon Function in Subjects Undergoing Surgical Repair of Flexor Tendons in Zone II of the Hand
Renovo16 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2009年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 44
- 试验地点
- 16
- 主要终点
- The primary trial endpoint will be the assessment of safety and local tolerability for a period up to twenty six weeks after dosing.
研究概览
简要总结
This study is being undertaken to verify the safety and performance of Adaprev™, a Class III medical device, when administered as a short term implant into the tendon sheath at the time of surgery, on the post-operative function of severed digital tendons. Subjects are randomised to either Adaprev or standard care and attend visits for 26 weeks following surgery. This clinical investigation will recruit 44 subjects in the UK at up to 10 clinical trial sites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 18 years and above with complete division of the Flexor Digitorum Profundus (FDP) tendon in Zone II.
排除标准
- •Subjects with additional complicated injuries
- •Subjects whose flexor tendon repair involves a finger with less than full tendon function prior to the injury requiring repair
- •Subjects who are undergoing surgical repair of the severed tendon(s) more than four days after the injury occurred.
- •Subjects with a history of clinical significant hypersensitivity to any of the devices, drugs or surgical dressings to be used in this trial.
- •Subjects with conditions which may delay healing.
- •Subjects who are taking, or have taken, any investigational drugs within 3 months prior to the screening visit.
- •Females who are pregnant
结局指标
主要结局
The primary trial endpoint will be the assessment of safety and local tolerability for a period up to twenty six weeks after dosing.
时间窗: 26 weeks post surgery
次要结局
- The secondary endpoint will be an evaluation of the performance of Adaprev™ as measured by the range of motion of the treated finger at twenty six weeks after tendon repair(26 weeks post surgery)
研究者
研究点 (16)
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