Evaluation of Gixam's Efficacy Predicting Pre-cancerous Colorectal Polyps and Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Jubaan Ltd.
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Safety - number of device related adverse events and serious adverse events
研究概览
简要总结
This is a prospective, single arm, multi-center clinical investigation aim to demonstrate the efficacy of Gixam in predicting the presence of premalignant colorectal polyps and colorectal cancer (CRC) in a fecal immunochemical test (FIT) positive population.
详细描述
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Average risk persons eligible for CRC screening that have received a positive FIT outcome in the past 6 months and are scheduled for a screening colonoscopy at one of the participating centers will be offered to participate in the study.
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Following the informed consent process, subjects will undergo the Gixam test.
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A subset of 50 subjects will participate in the repeatability assessment. They will undergo three (3) repetitive Gixam tests one after the other, by the same operator.
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Both the subject and the endoscopist will be blinded to the Gixam outcome
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All subjects will thereafter undergo a standard of care HD-WL colonoscopy procedure.
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All resected and retrieved lesions will be sent separately for histopathological evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Screening
- 盲法
- None
盲法说明
Participants and physician performing colonoscopy will be blinded to the Gixam outcome
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged ≥50 - ≤80 years.
- •Able to provide a signed informed consent.
- •Underwent FIT screening within the past 6 months with a positive result.
- •Scheduled for a FIT positive screening colonoscopy at investigational site.
排除标准
- •Has undergone colonoscopy within the past nine (9) years, except for a failed colonoscopy due to poor bowel preparation, which must have been performed within the past year without therapeutic intervention.
- •Personal history of CRC.
- •Family history of CRC, defined as having one or more first-degree relatives (parent, sibling, or child) with CRC at any age.
- •Subject has a diagnosis or medical / family history of any of the following conditions, including:
- •Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome),
- •Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome"),
- •Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis, or Familial Hyperplastic Polyposis.
- •Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis, and/or Crohn's disease, and/or IBD-undefined.
- •Subjects with the disability to extend their tongue.
- •Subjects with tongue piercing.
- •Dental visit in the 7 days prior to the Gixam test.
- •Intake of pro-biotics over the past 3 months pre-Gixam test.
- •Subject has any condition that in the opinion of the Investigator should preclude participation in the study.
结局指标
主要结局
Safety - number of device related adverse events and serious adverse events
时间窗: Through study completion, up to 30 days
Number of device related adverse events and serious adverse events
Efficacy - Gixam's sensitivity and specificity
时间窗: Through study completion, up to 30 days
Gixam's sensitivity and specificity to predict the presence of premalignant neoplastic colorectal polyps (advanced premalignant neoplastic lesions/non-advanced premalignant neoplastic lesion) and CRC
次要结局
未报告次要终点