Evaluation of C-Scan System in Providing Structural Information and Detection of Polypoid Lesions in High Risk Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03356002
• Date of registration: 20/11/2017
• Prospective Registration: Yes
• Primary sponsor: Check-Cap Ltd.
• Public title: Evaluation of C-Scan System in Providing Structural Information and Detection of Polypoid Lesions in High Risk Subjects
• Scientific title: Evaluation of C-Scan System in Providing Structural Information and Detection of Polypoid Lesions in High Risk Subjects
• Date of first enrolment: January 28, 2018
• Target sample size: 142
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03356002
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: Double (Care Provider, Investigator).
• Phase: N/A

Countries of recruitment

Israel

Contacts

• Name: Boaz Shpigelman
• Affiliation: VP R&D

Key inclusion & exclusion criteria

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



Age minimum: 40 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Counterindicated Patients for Colonoscopy

High Risk (Above Average) Subjects

Non Compliant Patients for Colo Rectal Cancer [CRC] Screening

Intervention(s)

Device: C-Scan System

Primary Outcome(s)

Sensitivity and specificity of C-Scan Capsule System in detecting per segment polypoid lesions 10 mm and up as compared with Colonoscopy [Time Frame: One year]

Secondary Outcome(s)

Calculation of the score of the C-Scan system to generate a 3D model of the colon [Time Frame: One year]

Quantify the variance of the Interpretation of the data from the C-Scan System between the reviewers [Time Frame: One year]

Sensitivity and specificity of C-Scan Capsule System in detecting patients with polypoid lesions 6=x=9 mm, compared with Optical Colonoscopy [Time Frame: One year]

Secondary ID(s)

CL-SY-01-0094

Source(s) of Monetary Support

Please refer to primary and secondary sponsors