Validation of CapsoVision CapsoCam® SV-3 Capsule Endoscopy System

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.

Study Overview

• Status: Completed
• Conditions: Ulcer; Inflammatory Bowel Diseases; Celiac Disease; Crohn Disease; Intestinal Disease
• Intervention / Treatment: Device: SV-3 Capsule Endoscopy

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 Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Saratoga, California, United States, 95070
      • CapsoVision, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Ability to download images	Images are correctly downloaded using the CapsoAccess Capsule Data Access System (CDAAS3).	2 weeks
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

Collaborators and Investigators

• Sponsor: Capso Vision, Inc.
• Collaborators: Generic Devices Consulting, Inc.
• Investigators: Principal Investigator: David Shields, MD, CapsoVision Research Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2015
• Primary Completion (ACTUAL): June 11, 2020
• Study Completion (ACTUAL): June 11, 2020

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: September 28, 2020
• First Posted (ACTUAL): October 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 5, 2020
• Last Update Submitted That Met QC Criteria: September 28, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Crohn Disease; Inflammatory Bowel Diseases; Celiac Disease; Ulcer; Polyp; Intestinal Disease; Angioectasia
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Gastroenteritis; Malabsorption Syndromes; Inflammatory Bowel Diseases; Celiac Disease; Crohn Disease; Intestinal Diseases
• Other Study ID Numbers: CVI-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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