Feasibility, Multi-center prospective study of Check-Cap's P1 Capsule System in Patients eligible for CRC screening

• Conditions: colorectal cancer; 10017934; 10017991; 10017998

• Registration Number: NL-OMON39301
• Lead Sponsor: Check Cap Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective<br /><br>To establish the safety and preliminary efficacy of Check-Cap*s P1 Capsule<br /><br>System in patients eligible for CRC screening </p><br>