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

NCT05268406 | Unknown

• 1 other identifier: CL-SY-01-0099
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Incidence of device or procedure related adverse events

  Up to 7 days post C-Scan procedure completion

• Satisfaction with the C-Scan procedure assessed by a questionnaire

  Up to 7 days post C-Scan procedure completion

• Satisfaction with the C-Scan procedure compared to colonoscopy assessed by a questionnaire

  Up to 7 days post colonoscopy

• Evaluate the Whole Gut Transit Time

  During the C-Scan procedure

Study Arms (1)

Single arm

EXPERIMENTAL

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

Device: C-Scan System

Interventions

C-Scan System DEVICE

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.

Single arm

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subject who is not a suitable candidate for a colonoscopy
• Known history of dysphagia or other swallowing disorders.
• 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)
• GI bleeding within the last 3 months i.e., rectal outlet bleeding, hematochezia or melena
• Known motility disorders:
• Chronic Constipation: less than three (3) bowel movements/week, without the use of laxatives within the last 3 months.
• Delayed gastric emptying.
• Ongoing diarrhea defined as passage of loose or watery stools at least three times in a 24-hour.
• Known IBD (Crohn's, ulcerative Colitis)
• Prior history of gastrointestinal tract surgery.

Sponsors & Collaborators

• Check-Cap Ltd.: lead

Study Sites (10)

Emek Medical Center

Afula, Israel

RECRUITING

Soroka Medical Center

Beersheba, 3030000, Israel

TERMINATED

Bnei Zion Medical center

Haifa, Israel

RECRUITING

Lin- Clalit

Haifa, Israel

RECRUITING

Rambam Medical Center

Haifa, Israel

RECRUITING

Talpiot- Clalit

Jerusalem, Israel

TERMINATED

Meir Medical Center

Kfar Saba, Israel

RECRUITING

Galil Medical Center

Nahariya, Israel

RECRUITING

Laniado Medical Center

Netanya, Israel

RECRUITING

Tel Aviv Medical Center

Tel Aviv, Israel

RECRUITING

Study Officials

• Nadir Arber, Professor

  Tel Aviv Medical Center, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanit Brenner- Lavie, PhD

CONTACT

97248303401; hanit.brenner@check-cap.com

Daniella Bleistein, MSc

CONTACT

972-4-8303401; daniella.bleistein@check-cap.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 7, 2022
• Study Start: July 29, 2020
• Primary Completion: May 31, 2023
• Study Completion: August 31, 2023
• Last Updated: December 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (10)