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

NCT05271656 | Terminated FDA Device

• 1 other identifier: CL-SY-02-0100
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 3

Brief Summary

The main objective of the study is to determine the ability of the C-Scan system to identify subjects who are at elevated risk for colon polyps. This will be evaluated by comparing the C-Scan data to colonoscopy data. The C-Scan procedure is therefore performed before the colonoscopy procedure, in order to compare these tests and evaluate the C-Scan system's effectiveness. During the C-scan procedure, Subjects will be asked to come for an appointment in a clinic, during this appointment, the C-Scan Track will be placed on the participant's back. The participant will then be asked to swallow the C-Scan capsule whereafter they are free to continue their routine. Participants will start intake of fiber pills 5 days, and contrast agent 48 hours prior to C-Scan capsule ingestion and will continue intake up to the capsule's natural excretion. A standard colonoscopy procedure will be performed within 60 days following C-Scan Cap ingestion.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Demonstrate the accuracy of the C-Scan system in identifying subjects with colon polyps comparing to optical colonoscopy (OC).

  For each subject the primary efficacy endpoints are dichotomous diagnosis using the C-Scan device (Test) and optical colonoscopy (Reference standard). Reference standard will be considered "positive" ("1") if at least one polyp of at least 6 mm is found. Test will be considered with elevated risk for polyps ("1") if either at least one polyp of at least 6 mm is found or long WGTT\* occurred. The above endpoints will be used to calculate sensitivity and specificity examined in the primary analysis. \*Long WGTT is defined as more than 73 hours for male and more than 97 hours for female.

  60 days

Secondary Outcomes (5)

• Negative predictive value for ruling out polyps of at least 10 mm.

  60 days

• Sensitivity of C-Scan for detecting polyps of at least 10mm.

  60 days

• Demonstrate the safety of the C-Scan System

  7±3 days from capsule excretion

• Demonstrate subjects' satisfaction and usability with the C-Scan System

  7±3 days from capsule excretion

• Demonstrate subjects' satisfaction with the C-Scan System compared to optical colonoscopy

  4-10 days post colonoscopy

Study Arms (1)

C-Scan System

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 of fiber pills 5 days, and contrast agent 48 hours prior to scheduled C-Scan capsule ingestion. 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.

Also known as: Optical colonoscopy

C-Scan System

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects 45-75 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 no later than 60 days after C-Scan ingestion
• Maximal 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:
• Colorectal polyps
• A personal history of CRC
• A family history of CRC or adenomatous polyps diagnosed in a relative before 60 years of age
• A history of inflammatory bowel disease of significant duration
• One of two (2) hereditary syndromes
• Known motility disorders:
• Chronic Constipation: less than three (3) bowel movements/week, without the use of laxatives within the last 3 months.
• Ongoing diarrhea defined as passage of loose or watery stools at least three times within 24-hour
• Delayed gastric emptying.
• Known IBD (Crohn's, Ulcerative Colitis)
• Prior history of gastrointestinal tract surgery.
• Prior history of abdominal surgery that might cause bowel strictures leading to capsule retention, as determined by a physician

Sponsors & Collaborators

• Check-Cap Ltd.: lead

Study Sites (3)

Mayo Clinic

Phoenix, Arizona, 85259, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The Sponsor and the C-Scan data analysis team shall be blind to subject's optical colonoscopy data until the C-Scan report is created.
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 9, 2022
• Study Start: May 10, 2022
• Primary Completion: July 26, 2023
• Study Completion: July 26, 2023
• Last Updated: July 28, 2023

Record last verified: 2023-07

Locations

US (3)