Validation of CapsoVision CapsoCam® SV-3 Capsule Endoscopy System

Capso Vision

Status: Completed

Conditions: Intestinal Disease; Ulcer; Celiac Disease; Inflammatory Bowel Diseases; Crohn Disease

Treatments: Device: SV-3 Capsule Endoscopy

Study type: Interventional

Funder types: Industry

Identifiers

NCT04573959

CVI-006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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84 participants in 1 patient group

SV-3 Capsule Endoscopy

Experimental group

Description:

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

Treatment:

Device: SV-3 Capsule Endoscopy