CTRI/2022/04/042235尚未招募4 期
A prospective, observational and multi-center study to characterize the safety, efficacy and performance of the LATEX FOLEY BALLOON CATHETER (2-WAY & 3-WAY)
STERIMED MEDICAL DEVICES PVT LTD1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年4月30日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To demonstrate clinical safety and efficacy of the Latex Foley Balloon Catheter (2 Way and 3Way) and to observe any undesirable events under normal condition of use
研究概览
简要总结
| The purpose of the study is to characterize the safety, efficacy and performance of the LATEX FOLEY BALLOON CATHETER (2-WAY & 3-WAY). People of any age undergoing general, gynecological, neuro, urethral and orthopedic surgeries (anesthesia patients) including use in plastic surgery that involve urine drainage from the bladder through urinary catheterization. |
All the potential patients that have been catheterized with LATEX FOLEY BALLOON CATHETER (2-WAY & 3-WAY).
A written informed consent will be taken from all study subjects.
All the subjects will be contacted telephonically for follow-up data.
Baseline, Procedural, and follow-up data will be collected and reported in the Case report form (CRF).
The data collected in CRF will be taken up for analysis and evaluation.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •All subjects who undergo urinary catheterization.
- •Both Male and Female patients will be enrolled.
- •Patients who have been treated with LATEX FOLEY BALLOON CATHETER (2WAY & 3-WAY) -All patients who are willing to provide informed consent for participation in the study.
排除标准
- •Subjects not suitable for intervention with LATEX FOLEY BALLOON CATHETER (2-WAY & 3-WAY).
- •All subjects who are not willing to provide informed consent for participation in the study -Subjects having allergy to Latex -Subjects using silicone foley catheter.
结局指标
主要结局
To demonstrate clinical safety and efficacy of the Latex Foley Balloon Catheter (2 Way and 3Way) and to observe any undesirable events under normal condition of use
时间窗: 3 Months
次要结局
- To demonstrate the performance of Latex Foley Balloon Catheter (2 Way and 3Way)(3 months)
研究者
研究点 (1)
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