Evaluation of Check-Cap C-Scan System in Providing Structural Information and Detection of Polypoid Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 3
- 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 FIT.
详细描述
The subject will be invited to come to the clinic to sign the ICF and other related documents. Then they'll ingest the capsule typically during the morning hours. The subjects will be connected to the C-Scan Track and 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/TV 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.
Capsule procedure is completed upon capsule excretion or system vibro/auditory indication of 'End of Procedure'.
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
- 30 Years 至 80 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 30-80 years old
- •Subject provided signed informed consent
排除标准
- •Patients 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, IBD, Meckel's Diverticulum, Bowen Hernia, Mega Colon, fistulas or other strictures (doctors' discretion).
- •Subject with known motility disorder or Chronic Constipation
- •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)
- •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
研究组 & 干预措施
Up to 45 subjects
Subjects with known polyp lesions≥10mm which were not removed because of poor preperation or the need to perform polypectomy at hospital will ingest the C-Scan cap and then will be schduled to polypectomy. The subjects will perform FIT test during the procedure and it will be compared with C-Scan System results.
干预措施: C-Scan System (Device)
Up to 25 subjects
Subjects who were reffered to screening colonoscopy as an average risk for CRC will ingest the C-Scan cap and then will be schduled to polypectomy. The subjects will perform FIT test during the procedure and it will be compared with C-Scan System results.
干预措施: C-Scan System (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 capsulle system in variuos segements of the colon as compared with the results indicated in the report of the follow-up colonoscopy
次要结局
- Sensitivity and specificity of C-Scan Capsule System in detecting patients with polypoid lesions 6≤x≤9 mm, compared with Optical Colonoscopy(One year)