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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free ERCP for non-complex bile duct stone disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cholangioscopy | Experimental | Participants in this arm undergo radiation-free ERCP facilitated by cholangioscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholangioscopy | Procedure | Cholangioscopy used instead of fluoroscopy-based ERCP to facilitate clearance of bile duct stones. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stone clearance | Successful clearance of stones from the bile duct using cholangioscopy | During the cholangioscopy procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Duration | Duration of procedure | 5 minutes to 2.5 hours anticipated time frame |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Evaluation of adverse events following the procedure | up to 30 weeks post-procedure |
Inclusion Criteria:
Exclusion Criteria:
5) Complex post-surgical anatomy e.g. Billroth type II anatomy, Roux-en-Y-gastrojejunostomy
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28797911 | Derived | Barakat MT, Girotra M, Choudhary A, Huang RJ, Sethi S, Banerjee S. A prospective evaluation of radiation-free direct solitary cholangioscopy for the management of choledocholithiasis. Gastrointest Endosc. 2018 Feb;87(2):584-589.e1. doi: 10.1016/j.gie.2017.07.042. Epub 2017 Aug 7. |
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| ID | Term |
|---|---|
| D042883 | Choledocholithiasis |
| ID | Term |
|---|---|
| D003137 | Common Bile Duct Diseases |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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Prospective feasibility study to evaluate potential for cholangioscopy to facilitate radiation-free ERCP.
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| Spyglass DS Cholangioscope | Device | Cholangioscopy used instead of fluoroscopy-based ERCP to facilitate clearance of bile duct stones. |
|
| D002769 | Cholelithiasis |