Validation of CapsoVision CapsoCam® SV-3 Capsule Endoscopy System

Crohn Disease Clinical Trial

Official title:

Validation of CapsoVision CapsoCam® SV-3 Capsule Endoscopy System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04573959
• Other study ID #: CVI-006
• Status: Completed
• Phase: N/A
• Start date: October 1, 2015
• Est. completion date: June 11, 2020

Study information

• Verified date: September 2020
• Source: Capso Vision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: June 11, 2020
• Est. primary completion date: June 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	CapsoVision, Inc.	Saratoga	California

Sponsors (2)

Lead Sponsor	Collaborator
Capso Vision, Inc.	Generic Devices Consulting, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks
Primary	Ability to download images	Images are correctly downloaded using the CapsoAccess Capsule Data Access System (CDAAS3).	2 weeks
Primary	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.	2 weeks