Crohn Disease Clinical Trial
Official title:
Validation of CapsoVision CapsoCam® SV-3 Capsule Endoscopy System
NCT number | NCT04573959 |
Other study ID # | CVI-006 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 1, 2015 |
Est. completion date | June 11, 2020 |
Verified date | September 2020 |
Source | Capso Vision, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | CapsoVision, Inc. | Saratoga | California |
Lead Sponsor | Collaborator |
---|---|
Capso Vision, Inc. | Generic Devices Consulting, Inc. |
United States,
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 |
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