Evaluation of Check-Cap C-Scan System in Providing Structural Information and Detection of Polypoid Lesions in Subjects at Average or High Risk for CRC
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 4
- 主要终点
- Safety- Number of incidents of trial duration above 300 hours
研究概览
简要总结
Up to 300 subjects will participate in this study. Subjects to be enrolled in this study are typically healthy and at average or high risk for CRC.
Each subject will undergo study assessments including a pre-screening telephone call, Procedure Visit, follow up post-ingestion via telephone calls.
On the day of the procedure, before administering the C-Scan. Once informed consent is obtained, a thorough evaluation of subject's eligibility will be performed based on inclusion / exclusion criteria. Medical history and concomitant medications information will be collected for all subjects. Also prior surgeries or endoscopic examinations showing pathology and current or previous GI problems or symptoms will be evaluated.
Some subjects will be asked to participate in additional ingestions (up to three, one at a time, at least one week intermission between the ingestions), to compare the performance of the system in different configuration on the same subject.
Each subject's participation in the study will take up to 3 weeks (per one ingestion).
Some subjects will be asked to participate in addition ingestions (up to three, one at a time, at least one week intermission between the ingestions), to compare the performance of the system in different configuration on the same subject.
Overall study duration will be one year.
详细描述
Study Population:
A total of 300 healthy subjects, Male or female, at average or high risk for CRC will be enrolled for the study.
Visit 1: C-Scan Procedure Visit This visit is performed in order to ensure that the subject continues to meet all inclusion and has no exclusion criteria, and has had adequate time to review the consent form and to ask questions. Once it has been determined that the subject meets all inclusion and has no exclusion criteria, and the subject chooses to participate in the study, the consent form will be signed and dated by all appropriate parties prior to execution of study-specific assessments. Signing the informed consent form signifies enrollment in the clinical study.
Capsule ingestion will take place at this visit. Additionally, the subject will receive detailed training session and instructions including explanation from the site study team about the device, its usage and the required documentation described below. Following subject training, the Capsule will be ingested ('C-Scan Initiation Procedure') at this visit, as described below.
C-Scan Initiation 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
- Single (Outcomes Assessor)
盲法说明
3 independent reviewers, licensed physicians, trained with reviewing and analyzing C-Scan System scans, will evaluate all study subjects original scans for potential findings, including type, location and size. All reviewers will be blinded to the subject groups (symptoms, classification etc.)
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
- •Male or female at the age of 40-80 years old
- •Subjects who are ready to undergo the monitoring routine
- •Subject provided signed informed consent
排除标准
- •Subjects with advanced cancer or other life threatening diseases or conditions
- •Subjects with known history of dysphagia or other swallowing disorders
- •Subjecta 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 (less than 3 bowel movements/week)
- •Subject with known delayed gastric emptying
- •Subjects 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 low BMI (BMI<20) or Obese (BMI≥ 38)
- •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
- •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
Healthy subjects at averge risk for CRC
All subjects are healthy who didn't have any known polyps in past colonoscopy and who arw candidates for CRC screening
干预措施: C-Scan System (Device)
Healthy subjects at high risk for CRC
Subjects who had polyps in former colonoscopy, subjects who have family history of CRC or subjects who have positive stool blood test.
干预措施: C-Scan System (Device)
结局指标
主要结局
Safety- Number of incidents of trial duration above 300 hours
时间窗: 12 months
The duration of the study procedures will be no more than 12.5 days
Safety measurments of the C-Scan System regarding SUSAR
时间窗: 12 months
No Incidents of SUSAR according to CTCAE scale
Evaluation of the performance of the C-scan System in detecting polyps≥10 mm compared to FIT results
时间窗: 12 months
rate of Positive and Negative Agreement of C-Scan System compared to FIT in detecting subjects with polypoid lesions ≥10 mm
次要结局
未报告次要终点