Evaluation of Check-Cap C-Scan System in Providing Structural Information and Detection of Polypoid Lesions

NCT02990715 | Completed

• 1 other identifier: CL-SY-01-0093
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to establish the efficacy of Check-Cap's C-Scan System in providing structural information on colonic polypoid lesions and masses, as an adjacent tool to FIT.

Conditions

Polypoid Lesions

Keywords

average risk CRC screening; Non compliant patients for CRC screening; Counterindicated patients for colonoscopy

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of C-Scan Capsule System in detecting per segment polypoid lesions 10 mm and up as compared with Colonoscopy

  Number of polyps detected by the capsulle system in variuos segements of the colon as compared with the results indicated in the report of the follow-up colonoscopy

  One year

Secondary Outcomes (1)

• Sensitivity and specificity of C-Scan Capsule System in detecting patients with polypoid lesions 6≤x≤9 mm, compared with Optical Colonoscopy

  One year

Study Arms (2)

Up to 45 subjects

ACTIVE COMPARATOR

Subjects with known polyp lesions≥10mm which were not removed because of poor preperation or the need to perform polypectomy at hospital will ingest the C-Scan cap and then will be schduled to polypectomy. The subjects will perform FIT test during the procedure and it will be compared with C-Scan System results.

Device: C-Scan System

Up to 25 subjects

EXPERIMENTAL

Subjects who were reffered to screening colonoscopy as an average risk for CRC will ingest the C-Scan cap and then will be schduled to polypectomy. The subjects will perform FIT test during the procedure and it will be compared with C-Scan System results.

Device: C-Scan System

Interventions

C-Scan System DEVICE

1. To establish the efficacy of C-Scan Capsule System and FIT in detecting patients with polypoid lesions ≥ 10mm, compared with Optical Colonoscopy 2. To evaluate the safety of the C-Scan Capsule System procedure

Also known as: Colon capsule

Up to 25 subjects; Up to 45 subjects

Eligibility Criteria

• Age: 30 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 30-80 years old
• Subject provided signed informed consent

You may not qualify if:

• Patients 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, IBD, Meckel's Diverticulum, Bowen Hernia, Mega Colon, fistulas or other strictures (doctors' discretion).
• Subject with known motility disorder or Chronic Constipation
• 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)
• 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

Sponsors & Collaborators

• Check-Cap Ltd.: lead

Study Sites (3)

Emek Medical Center

Afula, Galilee, Israel

Location

Rambam Medical Center

Haifa, North, Israel

Location

Sourasky Medical Center

Tel Aviv, 64000, Israel

Location

Study Officials

• Alex Ovadia

  COO, VP R&D

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: The colonoscopists will be blinded to the C-Scan system results and FIT results and the reviewers of C-Scan system results will be blinded to Fit and colonoscopy results
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: December 13, 2016
• Study Start: November 1, 2016
• Primary Completion: September 10, 2017
• Study Completion: September 13, 2017
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (3)