Clinical trial · Interventional
Safety,Usability and Compliance of Using C-Scan System for Providing Information on Colonic Polypoid Lesions and Masses
Evaluation of Safety, Usability and Subject Compliance While Using Check- Cap's C-Scan System for Providing Structural Information on Colonic Polypoid Lesions and Masses
- 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)
Protocol Title: Evaluation of safety, usability and subject compliance while using Check- Cap's C-Scan System for providing structural information on colonic polypoid lesions and masses Study Design: Prospective, Multi-center, Single-arm, safety study Purpose: To demonstrate the safety of the Check-Cap C-Scan System Study Centers: Up to two (2) centers located in the United States Number of Participants: 45 healthy subjects Investigational Device: Check-Cap's C-Scan System comprises C-Scan Capsule, C-Scan Track and C-Scan View. Primary Objective: To evaluate the safety of the Check-Cap C-Scan System Secondary Objectives: a. To evaluate subject's compliance b. To evaluate subject's satisfaction c. To collect data to improve the product's algorithm
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 |
|---|---|---|---|
| Colo-rectal Cancer | Colon Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| C-Scan procedure | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- C-Scan procedure
- description
- Subjects who are at high or at average risk for developing CRC and who are scheduled for optical colonoscopy will undergo C-Scan procedure
- interventionNames
- Device: C-Scan procedure
Primary outcomes (1)
- measure
- Number of Incidence of Device and Procedure Related Serious Adverse Events (SAE)
- timeFrame
- 6 Months
- description
- The safety of the Check-Cap System will be evaluated by the incidence of device and procedure related Serious Adverse Events (SAE), as adjudicated by the Independent Physician Adjudicator.
Secondary outcomes (2)
- measure
- Non-compliance Rate of Subjects (%)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female at the age of 40-80 years' old. 2. Subject provided signed informed consent. 3. Subject is willing and able to comply with the specified study requirements and follow-up evaluations, and can be contacted by telephone. 4. Subjects able and agrees to undergo colonoscopy procedure. 5. BMI \> 22 and ≤ 35. 6. Maximum body (abdominal) circumference \< 120 cm. 7. Has at least 3 bowel movements per week 8. A colonoscopy procedure is pre-scheduled within 60 days Exclusion Criteria:12.3 Exclusion Criteria 1. Known history of dysphagia or other swallowing disorders. 2. History of the followings: Inflammatory Bowel Disease (IBD) including Crohn's disease or Ulcerative, Colitis, Meckel's Diverticulum, Bowen Hernia, known fistulas or strictures (doctors' discretion), or a history of small bowel obstruction. 3. Known motility disorders: i. Chronic Constipation: less than 3 bowel movements/week, w/out the use of laxatives. ii. Delayed gastric emptying. iii. Narcotic use d. Prior history of abdominal surgery that might cause bowel strictures leading to capsule retention, as determined by physician discretion with the exception of appendectomy, cholecystectomy and hysterectomy e. Any condition believed to have an increased risk for capsule retention, strictures, bowel adhesion or other obstacles to free passage of the capsule (such as intestinal tumors, radiation enteritis) or incomplete colonoscopies (e.g. due to obstructions or NSAID enteropathy) as determined by physician discretion. f. Has a cardiac device (e.g. pacemaker or ICD-Implantable Cardioverter Defibrillator) or any other active implanted device g. Known sensitivity to iodine, or with known kidney failure. h. Known condition which precludes compliance or is contraindicated with study and/or device instructions. i. Has a Magnetic Image Resonance (MRI) procedure scheduled within 1 month j. Known condition of drug abuse and/or alcoholism. k. 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. l. Concurrent participation in another clinical trial using any investigational drug or device.
References
Publications (0)
Data not yet available