Evaluation of C-Scan in Identifying Subjects With Elevated Risk of Polyps in the Colon

The purpose of the first part of the study (subgroup R&D) is to demonstrate the safety and performance of the C-Scan system and to collect data in order to improve the analysis process. The purpose of the second part of the study (subgroup pre-pivotal) is to determine the ability of the C-Scan System to identify elevated risk subjects

Study Overview

• Status: Recruiting
• Conditions: Healthy Subjects
• Intervention / Treatment: Device: C-Scan System

• Study Type: Interventional
• Enrollment (Anticipated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hanit Brenner- Lavie, PhD; Phone Number: 97248303401; Email: hanit.brenner@check-cap.com
• Study Contact Backup: Name: Daniella Bleistein, MSc; Phone Number: 972-4-8303401; Email: daniella.bleistein@check-cap.com

Study Locations

• Israel
  • Afula, Israel
    • Recruiting
    • Emek medical center
    • Contact: Ian Gralnek, Professor
    • Principal Investigator: Ian Gralnek, Professor
  • Be'er Sheva, Israel, 3030000
    • Terminated
    • Soroka Medical Center
  • Haifa, Israel
    • Recruiting
    • Rambam Medical Center
    • Contact: Elizabeth half, M.D
    • Principal Investigator: Elizabeth Half, M.D
  • Haifa, Israel
    • Recruiting
    • Bnei Zion Medical Center
    • Contact: Tova Rainis, M.D
    • Principal Investigator: Tova Rainis, M.D
  • Haifa, Israel
    • Recruiting
    • Lin- Clalit
    • Contact: Hisham Shuli, M.D
    • Principal Investigator: Hisham Shuli, M.D
  • Jerusalem, Israel
    • Terminated
    • Talpiot- Clalit
  • Kefar Saba, Israel
    • Recruiting
    • Meir Medical Center
    • Contact: Yehuda Ringel, Professor
    • Principal Investigator: Yehuda Ringel, Professor
  • Nahariya, Israel
    • Recruiting
    • Galil Medical Center
    • Contact: Wisam Sbeit, M.D
    • Principal Investigator: Wisam Sbeit, M.D
  • Netanya, Israel
    • Recruiting
    • Laniado Medical Center
    • Contact: Atara Vatury; Email: aTvatury@laniado.org.il
    • Principal Investigator: Benny Shpak, MD
  • Tel Aviv, Israel
    • Recruiting
    • Tel Aviv Medical Center
    • Contact: Nadir Arber, Professor; Email: nadira@tlvmc.gov.il
    • Principal Investigator: Nadir Arber, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or Female at the age of 50-75 years old
2. Able to provide a signed informed consent.
3. Willing and able to comply with the specified study requirements and can be contacted by telephone.
4. Scheduled for colonoscopy procedure within 60 days of C-Scan ingestion within the research institution's system.*
5. Maximum body (abdominal) circumference < 125 cm.

Exclusion Criteria:

1. Subject who is not a suitable candidate for a colonoscopy

2. Known history of dysphagia or other swallowing disorders.

   Third (3rd) and fourth (4th) exclusion criteria are applicable to the pre-pivotal subgroup only:

3. History of the following:

   • Previous colon polyps
   • Personal history of CRC
   • Family history of CRC or adenomatous polyps diagnosed in a relative before age 60 years
   • History of inflammatory bowel disease
   • Having an inherited syndrome (Lynch syndrome, FAB)
4. GI bleeding within the last 3 months i.e., rectal outlet bleeding, hematochezia or melena

5. Known motility disorders:

   1. Chronic Constipation: less than three (3) bowel movements/week, without the use of laxatives within the last 3 months.
   2. Delayed gastric emptying.
   3. Ongoing diarrhea defined as passage of loose or watery stools at least three times in a 24-hour.
6. Known IBD (Crohn's, ulcerative Colitis)
7. Prior history of gastrointestinal tract surgery.
8. Prior history of abdominal surgery that might cause bowel strictures leading to capsule retention, as determined by physician discretion.
9. Any condition believed to have an increased risk for capsule retention, known strictures, any prior episode of bowel obstruction: known bowel adhesion, any 'obstacles' to free passage of the capsule (such as intestinal tumors, radiation enteritis) or incomplete colonoscopies or incomplete colonoscopies as determined by physician discretion.
10. Significant change in diameter and frequency of stool within the last 3 months
11. Has an implanted cardiac device or any other implanted active device
12. Known sensitivity to iodine or hyperthyroidism
13. Acute kidney failure
14. Known condition which precludes compliance or is contraindicated with study and/or device instructions.
15. Has any procedure requiring contrast agent or which may introduce electronic interference (such as magnetic resonance imaging, DEXA scan) or an imaging procedure pre-scheduled within 14 days of C-Scan ingestion
16. Nuclear imaging procedure during 4 weeks before C-Scan procedure
17. Known condition of opioid use disorder and/or alcoholism.
18. Women who are either pregnant or nursing at the time of screening (to be verified by urine or serum pregnancy test for woman of child- bearing potential who are not post-menopausal or undergone surgical sterilization(
19. Concurrent participation in another clinical trial using any investigational drug or device.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single arm; All study participants will undergo the C-Scan System procedure, followed by a standard of care optical colonoscopy

Device: C-Scan System; Subjects will be provided with contrast agent and dietary fiber pills, and instructed to start intake approximately 48 hours prior to the planned C-Scan procedure start. C-Scan system intervention includes ingestion of the C-Scan Cap and attachment of the C-Scan track to the subject's lower back. The subject is required to keep the C-Scan Track attached to the lower back and to continue intake of contrast agent and dietary fiber pills until the C-Scan Cap's natural excretion. Standard of care optical colonoscopy will be performed within 60 days from the C-Scan Cap ingestion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the ability of the C-Scan System to identify elevated risk subjects	Sensitivity for detecting subjects with elevated risk for polyps	60 days
Determine the ability of the C-Scan System to identify elevated risk subjects	Specificity for detecting subjects with elevated risk for polyps	60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of device or procedure related adverse events	Analysis of safety data	Up to 7 days post C-Scan procedure completion
Satisfaction with the C-Scan procedure assessed by a questionnaire	Satisfaction questionnaire to be completed by the subject	Up to 7 days post C-Scan procedure completion
Satisfaction with the C-Scan procedure compared to colonoscopy assessed by a questionnaire	Satisfaction questionnaire to be completed by the subject	Up to 7 days post colonoscopy
Evaluate the Whole Gut Transit Time	Time elapsed from capsule ingestion to excretion	During the C-Scan procedure

Collaborators and Investigators

• Sponsor: Check-Cap Ltd.
• Investigators: Principal Investigator: Nadir Arber, Professor, Tel Aviv Medical Center, Israel

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2020
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): August 31, 2023

Study Registration Dates

• First Submitted: February 15, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): March 7, 2022

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CL-SY-01-0099

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No