NCT04573959

Validation of CapsoVision CapsoCam® SV-3 Capsule Endoscopy System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Capso Vision, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	SV-3 Capsule Endoscopy	The purpose of this study is to validate an updated version of the CapsoCam SV-3 Endoscopy System with respect to the reproducibility of the system to capture and download small bowel images in a manner consistent with the predicate CapsoCam SV-3 capsule endoscopy.

Timeline

• Start date: 2015-10-01
• Primary completion: 2020-06-11
• Completion: 2020-06-11
• First posted: 2020-10-05
• Last updated: 2020-10-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study