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The Evolution® Biliary Stent System Clinical Study is a clinical trial on a commercially available device to gather physician experience with the Cook Evolution® Biliary Stent System for the palliation of cancer in the biliary tree. Patients will be treated as per usual medical practices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evolution® Biliary Stent - Uncovered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evolution® Biliary Stent - Uncovered | Device | Commercially available device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from symptomatic recurrent biliary obstruction requiring reintervention | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Technical success is defined as a stent successfully delivered and placed at its intended location at the end of the procedure. | Immediately following completion of the stent placement procedure |
| Incidence of device-related adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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Candidates for biliary stent placement based on institutional guidelines and product IFU.
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Lawrence | Summerville GI & Advanced Endoscopy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile Infirmary Medical Center | Mobile | Alabama | 36607 | United States | ||
| The Pancreas and Biliary Center of South Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32522161 | Derived | Lawrence C, Nieto J, Parsons WG, Roy A, Guda NM, Steinberg SE, Hasan MK, Bucobo JC, Nagula S, Dey ND, Buscaglia JM; Study Investigators. A newly designed uncovered biliary stent for palliation of malignant obstruction: results of a prospective study. BMC Gastroenterol. 2020 Jun 10;20(1):184. doi: 10.1186/s12876-020-01325-9. |
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| 6 months |
| Ease of use | Ease of use will be evaluated on a five point scale ranging from very easy to very difficult. | Immediately following completion of the stent placement procedure |
| Boca Raton |
| Florida |
| 33486 |
| United States |
| Borland-Groover Clinic | Jacksonville | Florida | 32256 | United States |
| Florida Hospital | Orlando | Florida | 32803 | United States |
| Northwest Community Hospital | Arlington Heights | Illinois | 60005 | United States |
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | United States |
| SUNY at Stony Brook Hospital | Stony Brook | New York | 11794 | United States |
| Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| Centre Hospitalier de l' Universite de Montreal (CHUM) | Montreal | Quebec | H2X 3J4 | Canada |
| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| D009369 | Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D001660 | Biliary Tract Diseases |
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