At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of Safety, Usability and Subject Compliance While Using Check- Cap's C-Scan System for Providing Structural Information on Colonic Polypoid Lesions and Masses
In Brief
A clinical study evaluating C-Scan procedure for Colo-rectal Cancer. Completed, enrolled 45 participants across 1 site.
Detailed Summary
Protocol Title: Evaluation of safety, usability and subject compliance while using Check- Cap's C-Scan System for providing structural information on colonic polypoid lesions and masses Study Design: Prospective, Multi-center, Single-arm, safety study Purpose: To demonstrate the safety of the Check-Cap C-Scan System Study Centers: Up to two (2) centers located in the United States Number of Participants: 45 healthy subjects Investigational Device: Check-Cap's C-Scan System comprises C-Scan Capsule, C-Scan Track and C-Scan View. Primary Objective: To evaluate the safety of the Check-Cap C-Scan System Secondary Objectives: a. To evaluate subject's compliance b. To evaluate subject's satisfaction c. To collect data to improve the product's algorithm
Study Details
Timeline
Interventions
The subjects will be connected to the C-Scan Track and after successful system's activation. The subject will be asked to ingest the C-Scan Capsule with some water, contrast media The subject will be required to ingest daily dose (3 X 15 ml) of contrast media. Capsule procedure is completed upon capsule excretion. o Collecting procedure related data: Technical performance in normal daily routine, Segmental transit time,Procedure duration, Number of Bowel movements , Similarity between C-Scan results and colonoscopy Etc,