Safety,Usability and Compliance of Using C-Scan System for Providing Information on Colonic Polypoid Lesions and Masses
Colo-rectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03735407 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- C-Scan procedure (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Check-Cap Ltd.
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Incidence of Device and Procedure Related Serious Adverse Events (SAE) |
— | — |
| SECONDARY Non-compliance Rate of Subjects (%) |
40 | — |
| SECONDARY To Evaluate Subject's Satisfaction |
3.42 | — |
Summary
Eligibility Criteria
Inclusion Criteria
- Male or female at the age of 40-80 years' old.
- Subject provided signed informed consent.
- Subject is willing and able to comply with the specified study requirements and follow-up evaluations, and can be contacted by telephone.
- Subjects able and agrees to undergo colonoscopy procedure.
- BMI > 22 and ≤ 35.
- Maximum body (abdominal) circumference < 120 cm.
- Has at least 3 bowel movements per week
- A colonoscopy procedure is pre-scheduled within 60 days
Exclusion Criteria:12.3 Exclusion Criteria
- Known history of dysphagia or other swallowing disorders.
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT03735407). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.