Michigan ENdoluminal Distraction Device (MENDD) Tolerance Assessment Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Discomfort as Assessed by Visual Analog Scale (VAS) for Radial Stretch
研究概览
简要总结
This study will utilize approved devices in an off-label manner to create forces required to induce intestinal lengthening. Radial and longitudinal forces are both required, and two devices will be used to create forces in order to test tolerability of said forces. This is to provide evidence that humans could tolerate the forces produced by a proposed commercially built device.
This study will test the hypothesis that radial and longitudinal forces necessary to produce enterogenesis will cause low levels of discomfort in healthy adults. Approved devices will be utilized in an off-label manner to reproduce forces similar to our novel medical device which is designed to treat short bowel syndrome (SBS).
This trial will not be testing a treatment for SBS, and individuals with SBS are ineligible for recruitment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Existing Ileostomy older than 6 weeks Undergoing any existing procedure in endoscopy suite or operating room.
排除标准
- •Inflammatory bowel disease of small bowel Pregnant Short bowel syndrome Bleeding disorder Chronic pain disorder Individuals taking chronic pain medications including prescriptions, cannabinoids or over the counter.
- •Individuals taking pain medications at the time of the procedure Cognitive Impairment to the extent that the questionnaire cannot be completed
结局指标
主要结局
Discomfort as Assessed by Visual Analog Scale (VAS) for Radial Stretch
时间窗: 1-2 Minutes
Participant discomfort will be assessed using VAS during radial stretch. The VAS is a scale ranging from 0 (no pain) to 10 (maximum pain).
次要结局
- Discomfort as Assessed by Visual Analog Scale for Longitudinal Stretch(Approximately 1 minute)
研究者
Meghan A. Arnold, MD
Clinical Associate Professor
University of Michigan