Validation of CapsoVision CapsoCam® SV-3 Capsule Endoscopy System

Study Overview
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Brief Summary
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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
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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.

Official Title
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Validation of CapsoVision CapsoCam® SV-3 Capsule Endoscopy System

Conditions
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Ulcer, Intestinal Disease, Inflammatory Bowel Diseases, Crohn Disease, Celiac Disease

Intervention / Treatment
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* Device: SV-3 Capsule Endoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SV-3 Capsule Endoscopy<br>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<br>* 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.<br>* Other names: Capsule Endoscopy System;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intestinal Disease, Inflammatory Bowel Diseases, Crohn Disease, Ulcer, Celiac Disease, Angioectasia, Polyp