Validation of CapsoVision CapsoCam® SV-3 Capsule Endoscopy System

Not Applicable

Completed

• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Celiac Disease; Intestinal Disease; Ulcer
• Interventions: Device: SV-3 Capsule Endoscopy

• Registration Number: NCT04573959
• Lead Sponsor: Capso Vision, Inc.

Brief 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.

Study Timeline

• Study Start: 2015-10-01
• Study First Submitted: 2020-02-07
• Primary Completion: 2020-06-11
• Study Completion: 2020-06-11
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-28
• Last Update Submitted: 2020-09-28
• Study First Posted: 2020-10-05
• Last Update Posted: 2020-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SV-3 Capsule Endoscopy	SV-3 Capsule Endoscopy	CapsoCam SV-3 Capsule Endoscopy system will perform in a manner consistent with the performance of the CapsoCam SV-3 capsule endoscopy systems.

Primary Outcome Measures

Name	Time	Method
Ability to capture images	2 weeks	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.
Diagnostic Quality of Images	2 weeks	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.
Ability to download images	2 weeks	Images are correctly downloaded using the CapsoAccess Capsule Data Access System (CDAAS3).

Trial Locations

Locations (1)

CapsoVision, Inc.; 🇺🇸 Saratoga, California, United States