Validation of CapsoVision CapsoCam® SV-3 Capsule Endoscopy System

• Sponsor: Capso Vision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04573959
• Collaborator: Generic Devices Consulting, Inc. (Industry)
• Enrollment: 84
• Location: 1
• Arm: 1
• Actual Duration (Months): 56.3
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intestinal Disease; Inflammatory Bowel Diseases; Crohn Disease; Ulcer; Celiac Disease	Device: SV-3 Capsule Endoscopy	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 84 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Validation of CapsoVision CapsoCam® SV-3 Capsule Endoscopy System
• Actual Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: Jun 11, 2020
• Actual Study Completion Date: Jun 11, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.; Other Names: Capsule Endoscopy System

Outcome Measures

Primary Outcome Measures

1. 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.

2. Ability to download images [2 weeks]

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

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CapsoVision, Inc.	Saratoga	California	United States	95070

Sponsors and Collaborators

• Capso Vision, Inc.
• Generic Devices Consulting, Inc.

Investigators

• Principal Investigator: David Shields, MD, CapsoVision Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Capso Vision, Inc.
• ClinicalTrials.gov Identifier: NCT04573959
• Other Study ID Numbers: CVI-006
• First Posted: Oct 5, 2020
• Last Update Posted: Oct 5, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Capso Vision, Inc.: Intestinal Disease; Inflammatory Bowel Diseases; Crohn Disease; Ulcer; Celiac Disease; Angioectasia; Polyp
• Additional relevant MeSH terms: Crohn Disease; Intestinal Diseases; Inflammatory Bowel Diseases; Celiac Disease

Study Results

No Results Posted as of Oct 5, 2020