NCT00737425Unknown4 期
Evaluation of Safety and Efficacy of the PainShield Device for the Treatment of Subjects Who Underwent Laparoscopic-Assisted Abdominal Surgery
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain and discomfort will be measured using appropriate validated questionnaires.
研究概览
简要总结
The purpose of this study is to evaluate safety and efficacy of PainShield device, based on ultrasound technology, for postoperative pain relief and wound healing following a laparoscopic-assisted abdominal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Subject's Age ≥ 18
- •Subject is able, agrees and signs the Informed Consent Form
- •Subject requires laparoscopic-assisted abdominal surgery
- •Incision size following the laparoscopy between 4-7 cm
排除标准
- •Epidural analgesia
- •Subject has any condition, which precludes compliance with study and/or device instructions
- •Subject is currently participating in another clinical study.
结局指标
主要结局
Pain and discomfort will be measured using appropriate validated questionnaires.
时间窗: Pain assessment will be performed daily
次要结局
- Infections will be assessed by concomitant antibiotic intake(Concomitant medications will be assessed daily)
研究者
研究点 (1)
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