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Evaluation of C-Scan System in Providing Structural Information and Detection of Polypoid Lesions in High Risk Subjects

NCT03356002 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2020-02-07

No results posted yet for this study

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 Feacal Immunochemical Test \[FIT\] in high risk subjects

Conditions

  • High Risk (Above Average) Subjects
  • Non Compliant Patients for Colo Rectal Cancer [CRC] Screening
  • Counterindicated Patients for Colonoscopy

Interventions

DEVICE

C-Scan System

Each subject will ingest the capsule within 30 days prior to colonoscopy. The results of the C-Scan review will be compared to the findings of colonoscopy. 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

Sponsors & Collaborators

  • Check-Cap Ltd.

    lead INDUSTRY

Principal Investigators

  • Boaz Shpigelman · VP R&D

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-28
Primary Completion
2020-01-26
Completion
2020-01-26

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03356002 on ClinicalTrials.gov