NCT05268406Unknown不适用
Evaluation of C-Scan in Identifying Subjects With Elevated Risk of Polyps in the Colon
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 800
- 试验地点
- 10
- 主要终点
- Determine the ability of the C-Scan System to identify elevated risk subjects
研究概览
简要总结
The purpose of the first part of the study (subgroup R&D) is to demonstrate the safety and performance of the C-Scan system and to collect data in order to improve the analysis process. The purpose of the second part of the study (subgroup pre-pivotal) is to determine the ability of the C-Scan System to identify elevated risk subjects
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
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female at the age of 50-75 years old
- •Able to provide a signed informed consent.
- •Willing and able to comply with the specified study requirements and can be contacted by telephone.
- •Scheduled for colonoscopy procedure within 60 days of C-Scan ingestion within the research institution's system.*
- •Maximum body (abdominal) circumference < 125 cm.
排除标准
- •Subject who is not a suitable candidate for a colonoscopy
- •Known history of dysphagia or other swallowing disorders.
- •Third (3rd) and fourth (4th) exclusion criteria are applicable to the pre-pivotal subgroup only:
- •History of the following:
- •Previous colon polyps
- •Personal history of CRC
- •Family history of CRC or adenomatous polyps diagnosed in a relative before age 60 years
- •History of inflammatory bowel disease
- •Having an inherited syndrome (Lynch syndrome, FAB)
- •GI bleeding within the last 3 months i.e., rectal outlet bleeding, hematochezia or melena
- •Known motility disorders:
- •Chronic Constipation: less than three (3) bowel movements/week, without the use of laxatives within the last 3 months.
- •Delayed gastric emptying.
- •Ongoing diarrhea defined as passage of loose or watery stools at least three times in a 24-hour.
- •Known IBD (Crohn's, ulcerative Colitis)
- •Prior history of gastrointestinal tract surgery.
- •Prior history of abdominal surgery that might cause bowel strictures leading to capsule retention, as determined by physician discretion.
- •Any condition believed to have an increased risk for capsule retention, known strictures, any prior episode of bowel obstruction: known bowel adhesion, any 'obstacles' to free passage of the capsule (such as intestinal tumors, radiation enteritis) or incomplete colonoscopies or incomplete colonoscopies as determined by physician discretion.
- •Significant change in diameter and frequency of stool within the last 3 months
- •Has an implanted cardiac device or any other implanted active device
- •Known sensitivity to iodine or hyperthyroidism
- •Acute kidney failure
- •Known condition which precludes compliance or is contraindicated with study and/or device instructions.
- •Has any procedure requiring contrast agent or which may introduce electronic interference (such as magnetic resonance imaging, DEXA scan) or an imaging procedure pre-scheduled within 14 days of C-Scan ingestion
- •Nuclear imaging procedure during 4 weeks before C-Scan procedure
- •Known condition of opioid use disorder and/or alcoholism.
- •Women who are either pregnant or nursing at the time of screening (to be verified by urine or serum pregnancy test for woman of child- bearing potential who are not post-menopausal or undergone surgical sterilization(
- •Concurrent participation in another clinical trial using any investigational drug or device.
研究组 & 干预措施
Single arm
Experimental
All study participants will undergo the C-Scan System procedure, followed by a standard of care optical colonoscopy
干预措施: C-Scan System (Device)
结局指标
主要结局
Determine the ability of the C-Scan System to identify elevated risk subjects
时间窗: 60 days
Sensitivity for detecting subjects with elevated risk for polyps
次要结局
- Evaluate the Whole Gut Transit Time(During the C-Scan procedure)
- Satisfaction with the C-Scan procedure assessed by a questionnaire(Up to 7 days post C-Scan procedure completion)
- Satisfaction with the C-Scan procedure compared to colonoscopy assessed by a questionnaire(Up to 7 days post colonoscopy)
- Incidence of device or procedure related adverse events(Up to 7 days post C-Scan procedure completion)
研究者
研究点 (10)
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