Validation of CapsoVision CapsoCam® SV-3 Capsule Endoscopy System

Crohn Disease Clinical Trial

Official title: Validation of CapsoVision CapsoCam® SV-3 Capsule Endoscopy System

Status Completed

Clinical Trial Summary

To validate an updated version of CapsoCam® SV-3 Endoscopy System brand name CapsoCam Plus™) with respect to the reproducibility of the system to capture and download small bowel images in a manner consistent with the predicate CapsoCam® SV-2 and SV-3 capsule endoscopy systems.

Clinical Trial Description

The purpose of the study is validate the an updated version of the CapsoCam® SV-3 Endoscopy System brand name CapsoCam Plus™) with respect to the reproducibility of the system to capture and download small bowel images in a manner consistent with the predicate CapsoCam® SV-2 and SV-3 capsule endoscopy systems.

The system to be validated consists of an updated version of the CapsoCam® SV-3 video capsule endoscope, the CapsoView® CVV Software, the CapsoAccess ® Capsule Data Access System (CDAS3) and the CapsoRetrieve® Capsule Retrieval Kit for the collection of the excreted CapsoCam capsule.

The captured CapsoCam® SV-3 capsule images of the small bowel will be downloaded via the CapsoAccess® Capsule Data Access System (CDAS3) to a computer and proprietary CapsoView® CVV Software is used to review capsule images. The CapsoView® software displays the video and employs a variety of image-enhancement, video playback, and image analysis features to facilitate physician review of the captured images. The software allows the physician to efficiently annotate individual frames from the video and compile a procedure report, which aids in diagnosis. ;

Related Conditions & MeSH terms

• Celiac Disease
• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Disease
• Intestinal Diseases
• Ulcer

• NCT number: NCT04573959
• Study type: Interventional
• Source: Capso Vision, Inc.
• Status: Completed
• Phase: N/A
• Start date: October 1, 2015
• Completion date: June 11, 2020