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This case series aims to document the clinical utility of intraoperative endoscopy using a thin, disposable, flexible cholangiopancreatoscope in procedures including but not limited to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with complex pancreaticobiliary disease | All subjects will undergo the intraoperative endoscopy with either the SpyGlass Discover System or the SpyGlass DS Direct Visualization System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SpyGlass Discover Digital System or SpyGlass DS Direct Visualization System | Device | Observational, prospective study for the clinical utility of the SpyGlass Discover Digital Catheter and the SpyScope DS Catheter during an intraoperative endoscopy procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Perform intraoperative endoscopy as intended using a thin, single-use, flexible cholangiopancreatoscope as desired, including but not limited to:
| During study procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | Serious adverse events related to the study device, accessory devices used throughout the working channel of the SpyGlass™ system, or the intraoperative endoscopy procedure | 1 month |
| Endoscopist rating of clinical impact of study procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with complex pancreaticobiliary disease
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health | Indianapolis | Indiana | 46202 | United States | ||
| Mayo Clinic |
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| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D001649 | Bile Duct Diseases |
| D004066 | Digestive System Diseases |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
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Characterization and rating of the clinical benefit and impact of intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope to the surgical procedure on a 1 (highly dissatisfied) to 10 (highly satisfied) scale |
| During study procedure |
| Adequate diagnostic yield | Adequate diagnostic yield of tissue biopsy for histopathology assessment | 1 month |
| Endoscopist rating of device | Rating of the intraoperative performance of the SpyGlass™ system and accessories during intraoperative endoscopy procedure compared to marketed reusable endoscopes on a 1 (highly dissatisfied) to 10 (highly satisfied) scale:
| During study procedure |
| Rochester |
| Minnesota |
| 55902 |
| United States |
| Lanzhou University No. 1 Hospital | Lanzhou | Gansu | 730000 | China |
| Prince of Wales Hospital | Shatin | New Territories | 999077 | Hong Kong |
| Asian Institute of Gastroenterology | Hyderabad | Telangana | 500032 | India |