colorectal cancer
Conditions
Interventions
None listed
Sponsors
Check Cap Ltd
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Male of female between 50 and 75 years of age - Patients which are generally healthy -Patients who are ready to undergo the capsule monitoring procedure and FOBT (or FIT) and the follow up colonoscopy examination - Have a significant clinical finding(s) in prior colon examination with suspected colon polyp: Virtual Colonoscopy or diagnostic colonoscopy. This criteria will apply to a cohort of at least 25 patients out of the total population - Sign informed consent.
Exclusion criteria
Exclusion criteria: Patients with known GI related symptoms, complains or GI diseases such as: - Crohn's disease -Colitis -IBD -Chronic constipation - Mega colon -Strictures in the GI tract - patients with cancer or other life threatening diseases or conditions Pregnant women (to be verified by test in case of doubt) •Patients who underwent any abdominal surgery •Patients who underwent any endoscopic examination showing pathology (except polyps) •Patients with cardiac pacer or any other implanted or external portable medical device (i.e. infusion pumps) •Bed-ridden or sedentary patients •Morbid Obesity (BMI > 40) •Patients who are unable to undergo the bowel preparation necessary for optical colonoscopy (based on previous attempts or self declaration) •Patients who are contraindicated from performing colon cleansing (bowel prep.) •Drug abuse or alcoholism •Patients under custodial care •Participation in current clinical study or clinical study within 30 days prior to the procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective To establish the safety and preliminary efficacy of Check-Cap*s P1 Capsule System in patients eligible for CRC screening | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objective • To evaluate the safety of the device in terms of total and segmental transit time. • To study the effect of the presence of polyps and variable colon dimensions on these parameters. • To monitor the functionality of the activation mechanism and of the scanning circuitry (transmitter detectors). • To collect data about the overall imaging of the colon internal surface during the passage of the capsule • Create an atlas of polyps images that enables comparison between images acquired by different modalities - P1 capsule system, Virtual Colonoscopy(if available as pre-study finding) and colonoscopy • To develop a correlation map between the imaging of the polyps by optical colonoscopy vs. the images of same polyps by Check- Cap*s P1 Capsule System vs. the imaging of same polyps by Virtual Colonoscopy (in patients which were referred after positive Virtual Colonoscopy examination) • To estimate the total radiation exposure to each patient. • To estimate the distribution of the contrast material within the colon. • To compare the clinical findings with those of FOBT or FIT | — |
Countries
Netherlands
Outcome results
None listed