Evaluation C-Scan System in Providing Structural Information and Polypoid Lesions in the Colon of Healthy Subjects

NCT04038736 | Completed

• 1 other identifier: CL-SY-01-0098
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 4

Brief Summary

Up to 300 subjects will participate in this study. Subjects to be enrolled in this study are typically healthy and at average or high risk for CRC. Each subject will undergo study assessments including a pre-screening telephone call, Procedure Visit, follow up post-ingestion via telephone calls. On the day of the procedure, before administering the C-Scan. Once informed consent is obtained, a thorough evaluation of subject's eligibility will be performed based on inclusion / exclusion criteria. Medical history and concomitant medications information will be collected for all subjects. Also prior surgeries or endoscopic examinations showing pathology and current or previous GI problems or symptoms will be evaluated. Some subjects will be asked to participate in additional ingestions (up to three, one at a time, at least one week intermission between the ingestions), to compare the performance of the system in different configuration on the same subject. Each subject's participation in the study will take up to 3 weeks (per one ingestion). Some subjects will be asked to participate in addition ingestions (up to three, one at a time, at least one week intermission between the ingestions), to compare the performance of the system in different configuration on the same subject. Overall study duration will be one year.

Conditions

Risk for Colorectal Cancer

Outcome Measures

Primary Outcomes (3)

• Safety- Number of incidents of trial duration above 300 hours

  The duration of the study procedures will be no more than 12.5 days

  12 months

• Safety measurments of the C-Scan System regarding SUSAR

  No Incidents of SUSAR according to CTCAE scale

  12 months

• Evaluation of the performance of the C-scan System in detecting polyps≥10 mm compared to FIT results

  rate of Positive and Negative Agreement of C-Scan System compared to FIT in detecting subjects with polypoid lesions ≥10 mm

  12 months

Study Arms (2)

Healthy subjects at averge risk for CRC

EXPERIMENTAL

All subjects are healthy who didn't have any known polyps in past colonoscopy and who arw candidates for CRC screening

Device: C-Scan System

Healthy subjects at high risk for CRC

EXPERIMENTAL

Subjects who had polyps in former colonoscopy, subjects who have family history of CRC or subjects who have positive stool blood test.

Device: C-Scan System

Interventions

C-Scan System DEVICE

During C-Scan procedure the subject swallows the C-Scan cap. The capsule travels painlessly through the gastrointestinal tract, seeking polyps, the precursors of colorectal cancer. It is essential to increase the stool's contrast by ingesting radio-opaque material. During the passage of the capsule in the gastrointestinal tract, it transmits information to a recorder attached to the back. In order to collect data about the instantaneous localization of the capsule traveling in the colon additional sensors are embedded in the recorder on the back side. After the capsule is expelled, the data from the recorder is downloaded to an acquisition workstation. Later, the data is transferred to a processing workstation where dedicated software visualizes and analyses the data.

Also known as: C-Scan Cap, C-Scan Track

Healthy subjects at averge risk for CRC; Healthy subjects at high risk for CRC

Eligibility Criteria

• Age: 40 Years - 80 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 40-80 years old
• Subjects who are ready to undergo the monitoring routine
• Subject provided signed informed consent

You may not qualify if:

• Subjects with advanced cancer or other life threatening diseases or conditions
• Subjects with known history of dysphagia or other swallowing disorders
• Subjecta with known history of GI disease or symptoms, such as: Crohn's disease, Colitis, 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
• Subjects 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 low BMI (BMI\<20) or Obese (BMI≥ 38)
• 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
• 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

Sponsors & Collaborators

• Check-Cap Ltd.: lead

Study Sites (4)

Bnai Zion Medical Center

Haifa, North, 33391, Israel

Location

Rambam Medical Center

Haifa, North, 3525408, Israel

Location

Haemek Medical Center

Afula, Israel

Location

Tel Aviv Sorasky Medical Center

Tel Aviv, Israel

Location

Study Officials

• Shlomo Lewkowicz, Dsc.

  Check-Cap

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 3 independent reviewers, licensed physicians, trained with reviewing and analyzing C-Scan System scans, will evaluate all study subjects original scans for potential findings, including type, location and size. All reviewers will be blinded to the subject groups (symptoms, classification etc.)
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Evaluation of the performance of the C-Scan System in providing structural information on colonic polypoid lesions and masses in average risk vs. high risk subjects.

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 31, 2019
• Study Start: December 26, 2019
• Primary Completion: December 27, 2020
• Study Completion: December 27, 2020
• Last Updated: February 17, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (4)