Evaluation of C-Scan System in Providing Structural Information and Detection of Polypoid Lesions in High Risk Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 7
- 主要终点
- Sensitivity and specificity of C-Scan Capsule System in detecting per segment polypoid lesions 10 mm and up as compared with Colonoscopy
研究概览
简要总结
The purpose of this study is to establish the efficacy of Check-Cap's C-Scan System in providing structural information on colonic polypoid lesions and masses, as an adjacent tool to Feacal Immunochemical Test [FIT] in high risk subjects
详细描述
The subject will be invited to come to the clinic to sign the Informed Consent Form [ICF] and other related .
The subjects will be connected to the C-Scan Track and following system's activation the subject will be asked to ingest the C-Scan Capsule with some water and contrast media, in the presence of a physician.
Post ingestion, the subject will be discharged home with clear instructions on the procedure. The subject should avoid intensive physical exercise during procedure or any extreme activities. The subject should make an effort to stay at home or other familiar surroundings, and may continue daily activities such mobile/computer/Television use, shower, sleep or eat. Details on allowed and restricted activities are listed in app. 4 The subject will be required to ingest daily dose (3 X 15-17ml) of contrast media, to be consumed three times per day with normal diet. Also on a need based the subject would be provided with laxadine (5 mg tablets) to be ingested according to the doctor recommendation.
During capsule procedure the subjects will be contacted by phone several times daily by the site clinical study team (or by dedicated external trained medical personnel), to assure the subjects well-being and to monitor for any change or discomfort and for procedure progress. Subjects may be also monitored by the technical team (either at home or at the clinic), who may need to examine the system or inquire the subjects about the system visual/auditory indicators.
The subjects will be provided with a dedicated capsule collection kit, to assist the subjects in collecting the capsule. Subjects will be instructed to retrieve the capsule upon excretion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Care Provider, Investigator)
盲法说明
The colonoscopists will be blinded to the C-Scan system results and FIT results and the reviewers of C-Scan system results will be blinded to Fit and colonoscopy results
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Subjects with advanced cancer or other life threatening diseases or conditions
- •Subject with known history of dysphagia or other swallowing disorders
- •Subject with known history of GI disease or symptoms, such as: Crohn's disease, Colitis, Inflammatory Bowel Disease [IBD], Meckel's Diverticulum, Bowen Hernia, Mega Colon, fistulas or other strictures (doctors' discretion).
- •Subject with known motility disorder or Chronic Constipation (less than 3 bowel movements/week)
- •Subject with known delayed gastric emptying
- •Subject with prior history of abdominal surgery that might cause bowel strictures leading to capsule retention, as determined by physician discretion
- •Subject with any condition believed to have an increased risk for capsule retention such as intestinal tumors, radiation enteritis, and incomplete colonoscopies due to obstructions or NSAID enteropathy, as determined by physician discretion
- •Subject with a cardiac pacemaker or other implanted electro medical device
- •Subjects with known sensitivity to iodine, or with kidney failure
- •Subjects with morbid obesity (BMI > 40)
- •Subjects with belly / girth circumference > 125 cm
- •Subject with any known condition which precludes compliance with study and/or device instructions
- •Subject with known condition of drug abuse and/or alcoholism
- •Subject who is unable to undergo colonoscopy or bowel preparation necessary for colonoscopy (based on previous attempts or self-declaration)
- •Women who are either pregnant or nursing at the time of screening (to be verified by test in case of woman of child-bearing potential that do not practice medically acceptable methods of contraception)
- •Concurrent participation in another clinical trial using any investigational drug or device
结局指标
主要结局
Sensitivity and specificity of C-Scan Capsule System in detecting per segment polypoid lesions 10 mm and up as compared with Colonoscopy
时间窗: One year
Number of polyps detected by the capsule system in various segments of the colon as compared with the results indicated in the report of the follow-up colonoscopy
次要结局
- Calculation of the score of the C-Scan system to generate a 3D model of the colon(One year)
- Sensitivity and specificity of C-Scan Capsule System in detecting patients with polypoid lesions 6≤x≤9 mm, compared with Optical Colonoscopy(One year)
- Quantify the variance of the Interpretation of the data from the C-Scan System between the reviewers(One year)