Celiac Disease, Crohn Disease, Inflammatory Bowel Diseases, Intestinal Disease, Ulcer
Conditions
Keywords
Intestinal Disease, Inflammatory Bowel Diseases, Crohn Disease, Ulcer, Celiac Disease, Angioectasia, Polyp
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.
Interventions
DEVICESV-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.
Sponsors
Generic Devices Consulting, Inc.
Capso Vision, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Ability to download images | 2 weeks | Images are correctly downloaded using the CapsoAccess Capsule Data Access System (CDAAS3). |
| 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. |
Countries
United States
Outcome results
None listed