Status:
COMPLETED
Evaluation C-Scan System in Providing Structural Information and Polypoid Lesions in the Colon of Healthy Subjects
Lead Sponsor:
Check-Cap Ltd.
Conditions:
Risk for Colorectal Cancer
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
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 includi...
Detailed Description
Study Population: A total of 300 healthy subjects, Male or female, at average or high risk for CRC will be enrolled for the study. Visit 1: C-Scan Procedure Visit This visit is performed in order to...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 27 2020
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04038736
Start Date
December 26 2019
End Date
December 27 2020
Last Update
February 17 2022
Active Locations (4)
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1
Bnai Zion Medical Center
Haifa, North, Israel, 33391
2
Rambam Medical Center
Haifa, North, Israel, 3525408
3
Haemek Medical Center
Afula, Israel
4
Tel Aviv Sorasky Medical Center
Tel Aviv, Israel