Predicting Adenomatous Polyps in the Colon, Using Images of a Human Tongue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Jubaan Ltd.
- 入组人数
- 426
- 试验地点
- 6
- 主要终点
- Primary Safety Endpoint - Number of device related adverse events and serious adverse events
研究概览
简要总结
This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the accuracy of the Gixam™ System in identifying subjects with colorectal adenomas compared to optical colonoscopy. Subjects arriving for a standard of care colonoscopy at the investigation site will be offered to participate in the study. Following an informed consent process, images of the subjects' tongue will be obtained with the Gixam™ System and a prediction score will be generated by the Gixam™ AI model. Subjects will thereafter proceed to their SOC colonoscopy, and the Gixam™ score will be compare with colonoscopy findings to evaluate its performance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
盲法说明
Gastroenterologist performing standard of care colonoscopy post Gixam test will be blinded to the Gixam prediction score.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females
- •Age: 18-75 years, inclusive
- •Scheduled for colonoscopy procedure at investigation site subject to one of the below criteria:
- •Screening - defined as first colonoscopy or consecutive colonoscopy without previous findings, previous colonoscopy performed at least 10 years ago (- 1 year);
- •Patient with finding of colorectal adenoma or sessile serrated polyp in previous colonoscopy (must be documented in patient's medical history).
- •Able to comprehend and provide informed consent.
排除标准
- •Subject who is not a suitable candidate for a colonoscopy
- •Lynch or Familial Adenomatous Polyposis (FAP) inherited syndromes
- •Current or previous Inflammatory Bowel Disease (IBD - Crohn's, Ulcerative Colitis) of significant duration
- •Patients with a disability to extend their tongue.
- •Patients with tongue piercings.
研究组 & 干预措施
Gixam followed by standard of care colonoscopy
This is a single-arm study. All participants will undergo the Gixam test following a standard of care colonoscopy
干预措施: Gixam (Device)
结局指标
主要结局
Primary Safety Endpoint - Number of device related adverse events and serious adverse events
时间窗: 1 day
Primary Efficacy Endpoint - Gixam's diagnostic accuracy
时间窗: 14 days (till pathology report is received)
Gixam's diagnostic accuracy (sensitivity and specificity) of adenomatous colorectal polyps. The Gixam's predictive value will be compared to the patient's colonoscopy + pathology (if any specimens are collected) findings as ground truth on a binary basis (YES/NO for adenomatous and sessile serrated polyps).
次要结局
未报告次要终点