Validation of CapsoVision CapsoCam® SV-3 Capsule Endoscopy System

Capso Vision, Inc.84 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Intestinal Disease Inflammatory Bowel Diseases Crohn Disease Ulcer Celiac Disease

Interventions

SV-3 Capsule EndoscopyDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or Female * Willing and able to provide written informed consent * Completion of pre-study questionnaire * Approval of study principal investigator Exclusion Criteria: * Subjects with abdominal pain of unknown origin * Difficulty Swallowing * Known or suspected gastrointestinal disease * Diarrhea or constipation * Anemia of unknown origin * Rectal or other gastrointestinal bleeding * Pregnancy

Locations (1)

CapsoVision, Inc.

Saratoga, California, United States

Outcomes

Primary Outcomes

Ability to capture images

Images are captured throughout an entire small bowel exam, with complete small bowel exam defined as the ability of the capsule to reach the cecum while still recording images.

Time frame: 2 weeks

Ability to download images

Images are correctly downloaded using the CapsoAccess Capsule Data Access System (CDAAS3).

Time frame: 2 weeks

Diagnostic Quality of Images

Small bowel images of diagnostic quality are able to be reviewed using the CapsoView CVV Software and determined to be effective for diagnostic purposes by the study investigator.

Time frame: 2 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.