Use of the Napoleon to Improve Polyp Measurement in Gastroenterology Fellows
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 4
- 主要终点
- Difference in accuracy of polyp measurement among fellow years
研究概览
简要总结
This is a clinical trial assessing gastroenterology fellows' accuracy of colonic polyp measurement using a Micro-Tech Endoscopic Polyp Measurement Device named Napoleon. The study will evaluate the feasibility of Napoleon as a polyp measurement device. Investigators will collect data on inpatient and outpatient colonoscopies performed by fellows at NYU Langone Health, NYU Langone Hospital Brooklyn, Bellevue Hospital Center, and Manhattan VA Medical Center from May 2021 - May 2022 for 150 patients. Investigators will include all colonoscopies with polyps done in adults age 45 and above. For each colonoscopy, a fellow will first visually estimate the polyp size and then measure the polyp with Napoleon. Investigators will calculate the difference in polyp measurement between visual assessment and using Napoleon for each fellow year and compare differences among fellow years. Investigators will evaluate for changes in fellows' accuracy of polyp measurement with subsequent uses of Napoleon. Investigators will determine the proportion of cases with a change in the recommended surveillance interval based on polyp size. A survey will be given to all fellows to assess the level of ease with using Napoleon.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Adult age 45 and above
- •Undergoing a colonoscopy performed by a gastroenterology fellow
- •Willingness and ability to provide informed consent
排除标准
- •History of not tolerating prior colonoscopies well or difficult colonoscopies (e.g. high sedative requirement)
- •Undergoing a diagnostic colonoscopy for inflammatory bowel disease or other known inflammatory/infectious process
- •An individual who meets any of the following criteria during the colonoscopy will be excluded from participation in this study:
- •Colonoscopy without polyps
- •Polyps not removed in entirety
- •Polyps with indeterminate size
- •An individual who meets any of the following criteria after the colonoscopy will be excluded from participation in this study:
- •1. Hyperplastic or non-adenomatous polyps on pathology report
- •Inclusion Criteria:
- •NYU gastroenterology fellow
- •Willingness and ability to provide informed consent
- •Exclusion Criteria:
- •1. Not deemed to be medically trained and ready to perform a colonoscopy by supervising gastroenterology attending
研究组 & 干预措施
Colonoscopy Patients + their Gastroenterology Fellows
Inpatient and outpatient colonoscopies performed by fellows at NYU Langone Health, NYU Langone Hospital Brooklyn, Bellevue Hospital Center, and Manhattan VA Medical Center from October 2020 - March 2021. These will include all colonoscopies with polyps done in adults age 45 and above.
干预措施: Visual estimation of polyp size (Other)
Colonoscopy Patients + their Gastroenterology Fellows
Inpatient and outpatient colonoscopies performed by fellows at NYU Langone Health, NYU Langone Hospital Brooklyn, Bellevue Hospital Center, and Manhattan VA Medical Center from October 2020 - March 2021. These will include all colonoscopies with polyps done in adults age 45 and above.
干预措施: Napoleon measurement of polyp size (Device)
结局指标
主要结局
Difference in accuracy of polyp measurement among fellow years
时间窗: 6 months
Proportion of cases with a difference in the recommended surveillance interval based on polyp size
时间窗: 6 months
Difference in polyp measurement between visual assessment and using Napoleon in fellows
时间窗: 6 months
Difference in fellows' accuracy of polyp measurement with subsequent uses of Napoleon
时间窗: 6 months
Difference in polyp measurement between histology and using Napoleon
时间窗: 6 months
次要结局
未报告次要终点