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This observational Non-Significant Risk (NSR) Study will be used to assess the ability of CapsoCam® Plus (SV-3) capsule endoscope to detect the duodenal papilla and visualize pathology or abnormalities in the periampullary area and will prospectively compare the capsule endoscopy and EUS/ERCP pictorial images acquired in procedures conducted in a minimum of 20 and a maximum of 200 research patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CapsoCam® Plus (SV-3) capsule endoscope | Experimental | Endoscope Capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CapsoCam® Plus (SV-3) capsule endoscope | Device | Endoscope Capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| The ability to detect and visualize the duodenal papilla | Rate of duodenal papilla detection | during capsule endoscopy procedure |
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Inclusion Criteria:
Exclusion Criteria:
Patients with existing biliary stent will be excluded
EUS/ERCP exclusion criteria: per medical practice, including:
Capsule Endoscopy (CE) exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84132 | United States |
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| ID | Term |
|---|---|
| D053705 | Capsule Endoscopes |
| ID | Term |
|---|---|
| D020776 | Endoscopes, Gastrointestinal |
| D019723 | Endoscopes |
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
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