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The purpose of this study is to evaluate the safety and performance of the WallFlex® Biliary RX Fully Covered Stent as a treatment of biliary obstruction resulting from benign bile duct strictures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WallFlex Biliary RX FC Stent System | Experimental | The WallFlex Biliary RX Fully Covered Stent System is being evaluated for treatment of benign biliary strictures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WallFlex Biliary RX Fully Covered Stent System | Device | Temporary placement of a biliary stent as a treatment of biliary obstruction resulting from benign bile duct strictures. The stent is fully covered with a silicone polymer to reduce the potential of tissue ingrowth into the stent. The stent is removed after 5 months (±1 month) after stent placement in Post-Liver Transplant patients and after 11 months (±1 month) in Chronic Pancreatitis and Post-Abdominal Surgery patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Stent Removability | Defined as ability to remove the stent endoscopically without serious stent removal related adverse events as assessed from the time of stent removal to 1month post-stent removal. | At stent removal |
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Inclusion Criteria:
Exclusion Criteria:
General:
Additional Specific to Chronic Pancreatitis Patients:
Additional Specific to Post-Abdominal Surgery Patients:
Additional Specific to Liver Transplant Patients:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia | ||
| Medical University of Vienna |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24801350 | Result | Deviere J, Nageshwar Reddy D, Puspok A, Ponchon T, Bruno MJ, Bourke MJ, Neuhaus H, Roy A, Gonzalez-Huix Llado F, Barkun AN, Kortan PP, Navarrete C, Peetermans J, Blero D, Lakhtakia S, Dolak W, Lepilliez V, Poley JW, Tringali A, Costamagna G; Benign Biliary Stenoses Working Group. Successful management of benign biliary strictures with fully covered self-expanding metal stents. Gastroenterology. 2014 Aug;147(2):385-95; quiz e15. doi: 10.1053/j.gastro.2014.04.043. Epub 2014 May 4. | |
| 32417298 |
| Label | URL |
|---|---|
| Successful management of benign biliary strictures with fully covered self-expanding metal stents. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | WallFlex Biliary RX FC Stent System | The WallFlex Biliary RX Fully Covered Stent System is being evaluated for treatment of benign biliary strictures. WallFlex Biliary RX Fully Covered Stent System: Temporary placement of a biliary stent as a treatment of biliary obstruction resulting from benign bile duct strictures. The stent is fully covered with a silicone polymer to reduce the potential of tissue ingrowth into the stent. The stent is removed after 5 months (±1 month) after stent placement in Post-Liver Transplant patients and after 11 months (±1 month) in Chronic Pancreatitis and Post-Abdominal Surgery patients. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | WallFlex Biliary RX FC Stent System | The WallFlex Biliary RX Fully Covered Stent System is being evaluated for treatment of benign biliary strictures. WallFlex Biliary RX Fully Covered Stent System: Temporary placement of a biliary stent as a treatment of biliary obstruction resulting from benign bile duct strictures. The stent is fully covered with a silicone polymer to reduce the potential of tissue ingrowth into the stent. The stent is removed after 5 months (±1 month) after stent placement in Post-Liver Transplant patients and after 11 months (±1 month) in Chronic Pancreatitis and Post-Abdominal Surgery patients. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Stent Removability | Defined as ability to remove the stent endoscopically without serious stent removal related adverse events as assessed from the time of stent removal to 1month post-stent removal. | 10 Patients were excluded because of death (from unrelated cause), withdrawal of consent, or switch to palliative treatment. | Posted | Count of Participants | Participants | At stent removal |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | WallFlex Biliary RX FC Stent System | evaluated for treatment of benign biliary strictures. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholangitis/fever | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jacques Devière, MD, PhD | Hôpital Erasme | (32) 0-2-555-4697. | Jacques.Deviere@erasme.ulb.ac.be |
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|
| Vienna |
| Austria |
| ULB Erasme Hospital | Brussels | Belgium |
| St. Michael's Hospital | Toronto | Ontario | Canada |
| Centre Hospitalier de l'Université de Montréal-Saint-Luc Hospital | Montreal | Quebec | H2X 3J4 | Canada |
| MUHC - McGill University | Montreal | Quebec | Canada |
| Clinica Alemana de Santiago | Santiago | Chile |
| Hopital Edouard Herriot | Lyon | France |
| Evangelischen Krankenhaus | Düsseldorf | Germany |
| Asian Institute of Gastroenterology | Hyderabad | India |
| Università Cattolica del Sacro Cuore Policlinico A. Gemelli | Rome | 00168 | Italy |
| Erasmus Medical Center | Rotterdam | Netherlands |
| Hospital Universitari Doctor Josep Trueta | Girona | Catalonia | Spain |
| Derived |
| Poley JW, Ponchon T, Puespoek A, Bruno M, Roy A, Peetermans J, Rousseau M, Lepilliez V, Dolak W, Tringali A, Blero D, Carr-Locke D, Costamagna G, Deviere J; Benign Biliary Stenoses Working Group. Fully covered self-expanding metal stents for benign biliary stricture after orthotopic liver transplant: 5-year outcomes. Gastrointest Endosc. 2020 Dec;92(6):1216-1224. doi: 10.1016/j.gie.2020.04.078. Epub 2020 May 15. |
| 31830897 | Derived | Tringali A, Reddy DN, Ponchon T, Neuhaus H, Llado FG, Navarrete C, Bruno MJ, Kortan PP, Lakhtakia S, Peetermans J, Rousseau M, Carr-Locke D, Deviere J, Costamagna G; Benign Biliary Stenoses Working Group. Treatment of post-cholecystectomy biliary strictures with fully-covered self-expanding metal stents - results after 5 years of follow-up. BMC Gastroenterol. 2019 Dec 12;19(1):214. doi: 10.1186/s12876-019-1129-3. |
| 31494135 | Derived | Lakhtakia S, Reddy N, Dolak W, Ponchon T, Bruno MJ, Bourke MJ, Neuhaus H, Roy A, Gonzalez-Huix Llado F, Kortan PP, Peetermans J, Rousseau M, Costamagna G, Deviere J; Benign Biliary Stenoses Working Group. Long-term outcomes after temporary placement of a self-expanding fully covered metal stent for benign biliary strictures secondary to chronic pancreatitis. Gastrointest Endosc. 2020 Feb;91(2):361-369.e3. doi: 10.1016/j.gie.2019.08.037. Epub 2019 Sep 5. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 51 |
| 187 |
| 0 |
| 187 |
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Cholecystitis | Gastrointestinal disorders | Systematic Assessment |
|
| Cholestasis | Gastrointestinal disorders |
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| Other | Gastrointestinal disorders | Systematic Assessment |
|
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