NCT07384559尚未招募不适用
Exploratory Study Investigating the Urinary Bladder During Intermittent Catheterization in Healthy and Spinal Cord Injured Male and Female Subjects Using an Upright MRI Scanner
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Is the quality of the 3D MRI images performed at Visit 2 sufficient for further use/analysis? (Y/N).
研究概览
简要总结
This is an exploratory study investigating morphological and physiological changes of the lower urinary tract and surrounding structures during IC use in individuals with SCI, and during normal voiding and IC use in healthy individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Has given written informed consent
- •Is at least 18 years old
- •Has full legal capacity
- •Is able (assessed by investigator) and willing to adhere to study procedures during study duration
- •Is able (assessed by investigator) to remain seated in the MRI scanner for minimum 20 minutes*
- •Known with SCI for a minimum of 1 year*
- •Has used IC as primary bladder emptying method for at least 3 months* * Only for SCI subjects
排除标准
- •Is participating in any other clinical investigation during this investigation
- •Has previously completed this investigation
- •Has any known allergic or hypersensitive reactions to any device or its ingredients used in the investigation
- •Is pregnant
- •Has had surgical procedures performed in the lower urinary tract.
- •Has active/recurrent bladder cancer
- •Has experienced autonomic dysreflexia within the last 2 years
- •Has any MRI-scanning contraindications, according to MR check list provided by the site (e.g. active implants like pacemaker, cochlear implant, event recorder, implanted insulin pump)
- •Has symptoms of UTI at times of inclusion, as judged by the investigator.
- •Has a body weight that exceeds the maximum of 150kg max
研究组 & 干预措施
MRI scan
Other
MRI scan of SCI and healthy male/female subjects during catheterization
干预措施: MRI scan (Other)
结局指标
主要结局
Is the quality of the 3D MRI images performed at Visit 2 sufficient for further use/analysis? (Y/N).
时间窗: up to 28 days
次要结局
未报告次要终点
研究者
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