Clinical trial · Interventional
Evaluation C-Scan System in Providing Structural Information and Polypoid Lesions in the Colon of Healthy Subjects
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Risk for Colorectal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| C-Scan System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Healthy subjects at averge risk for CRC
- description
- All subjects are healthy who didn't have any known polyps in past colonoscopy and who arw candidates for CRC screening
- interventionNames
- Device: C-Scan System
- type
- EXPERIMENTAL
- label
- Healthy subjects at high risk for CRC
- description
- Subjects who had polyps in former colonoscopy, subjects who have family history of CRC or subjects who have positive stool blood test.
- interventionNames
- Device: C-Scan System
Primary outcomes (3)
- measure
- Safety- Number of incidents of trial duration above 300 hours
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available