Status:
COMPLETED
Evaluation of C-Scan System in Providing Structural Information and Detection of Polypoid Lesions in High Risk Subjects
Lead Sponsor:
Check-Cap Ltd.
Conditions:
High Risk (Above Average) Subjects
Non Compliant Patients for Colo Rectal Cancer [CRC] Screening
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
The purpose of this study is to establish the efficacy of Check-Cap's C-Scan System in providing structural information on colonic polypoid lesions and masses, as an adjacent tool to Feacal Immunochem...
Detailed Description
The subject will be invited to come to the clinic to sign the Informed Consent Form \[ICF\] and other related . The subjects will be connected to the C-Scan Track and following system's activation th...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Male or female at the age of 40-80 years old
- Subject provided signed informed consent
- Subjects to be enrolled in this study are indicated and scheduled to undergo optical colonoscopy based on the following symptoms or by being classified as higher than average risk based on one or more of the following:
- Surveillance - Significant findings in previous optical colonoscopy Diagnostic - Polyps detected in virtual colonoscopy referred for polypectomy Diagnostic - Polyps detected in previous optical colonoscopy (community setting) referred for polypectomy Diagnostic - Positive FIT test
- Diagnostic - one or more of the typical symptoms:
- abdominal pain Change in bowel habits Anemia or overt bleeding in stool Significant weight loss
- 1st degree relatives of CRC subjects Alternatively average risk based on their age and demographics referred for screening for polyps.
- Exclusion Criteria:
- Subjects with advanced cancer or other life threatening diseases or conditions
- Subject with known history of dysphagia or other swallowing disorders
- Subject with known history of GI disease or symptoms, such as: Crohn's disease, Colitis, Inflammatory Bowel Disease \[IBD\], 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
- Subject 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 morbid obesity (BMI \> 40)
- 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
- Subject who is unable to undergo colonoscopy or bowel preparation necessary for colonoscopy (based on previous attempts or self-declaration)
- 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
Exclusion
Key Trial Info
Start Date :
January 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2020
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT03356002
Start Date
January 28 2018
End Date
January 26 2020
Last Update
February 7 2020
Active Locations (7)
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1
Rambam Medical Center
Haifa, North, Israel
2
Haemek Medical Center
Afula, Israel
3
Soroka Medical Center
Beersheba, Israel
4
Bnai-Zion Medical Center
Haifa, Israel