NCT01800903已完成不适用
Clinical Study Investigating Safety and Performance of a New Coating for Urinary Intermittent Catheters in Healthy Volunteers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Overall Discomfort During Catheterization
研究概览
简要总结
The aim of the study is to evaluate safety and performance of a new catheter coating,compared to the current SpeediCath coating.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- Male
- 接受健康志愿者
- 是
入选标准
- •Have given written informed consent and signed letter of authority
- •Be at least 18 years of age and have full legal capacity
- •Willing to refrain from using analgetics up to 24 hours prior to catheterization visits
排除标准
- •Abnormalities, diseases or surgical procedures performed in the lower urinary tract
- •Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination)
- •Participating in other interventional clinical investigations during this investigation (inclusion to termination) or have previously participated in this investigation (including run-in period)
- •Known hypersensitivity toward any of the test products -
结局指标
主要结局
Overall Discomfort During Catheterization
时间窗: 1 day
Evaluated by the subject on a 10 cm Visual Analog Scale (VAS), where 0 cm is no discomfort and 10 cm is the worst possible discomfort.
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
A Pilot Study Evaluating the Safety and Effectiveness of a New Pleural Catheter for the Medical Management of Symptomatic, Recurrent, Malignant Pleural EffusionsMalignant Pleural EffusionsNCT02227732C. R. Bard10
撤回
1 期
Clinical Study Evaluating Safety of a New Catheter for Urinary Intermittent Catheter in Healthy VolunteersSpinal Cord InjuryNCT01292941Coloplast A/S
已完成
不适用
Clinical Assessment of a New Catheter Surface Coating With Antimicrobial PropertiesRenal InsufficiencyNCT00621712Vantive Health LLC90
已完成
不适用
Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheter in Healthy VolunteersIncontinence, UrinaryNCT02965066Coloplast A/S28
已完成
不适用
Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheters in Healthy VolunteersIncontinence, UrinaryNCT02965105Coloplast A/S28