Validation of CapsoVision CapsoCam® SV-3 Capsule Endoscopy System

NCT ID: NCT04573959

Last Updated: 2020-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-01
• Study Completion Date: 2020-06-11

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SV-3 Capsule Endoscopy

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Capsule Endoscopy System

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Generic Devices Consulting, Inc.

INDUSTRY

Sponsor Role: collaborator

Capso Vision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Shields, MD

Role: PRINCIPAL_INVESTIGATOR

CapsoVision Research Center

Locations

CapsoVision, Inc.

Saratoga, California, United States

Countries

United States

Other Identifiers

CVI-006

Identifier Type: -

Identifier Source: org_study_id