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The purpose of this study is to generate clinical data to support the use of GORE® VIABIL® Biliary Endoprosthesis in the endoscopic and percutaneous treatment of benign biliary strictures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GORE VIABIL® Biliary Endoprosthesis | Other | Placement of GORE VIABIL® Biliary Endoprosthesis to establish duct patency |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GORE® VIABIL® Biliary Endoprosthesis | Device | Deployment of GORE® VIABIL® Biliary Endoprosthesis to the area of stricture |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safe Stent Removal | The stent removal is considered safe when the Study Device is removed successfully and without SAEs. | Upon Removal |
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| Measure | Description | Time Frame |
|---|---|---|
| Primary Device Patency | Primary device patency is defined as the freedom from device occlusion requiring intervention (during the treatment period). | 12 Months |
| Successful Delivery and Deployment | This requires successful delivery and deployment of the device at the intended site. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karel Caca, MD | Klinikum Ludwigsburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Ludwigsburg | Ludwigsburg | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | GORE VIABIL® Biliary Endoprosthesis | Placement of GORE VIABIL® Biliary Endoprosthesis to establish duct patency GORE® VIABIL® Biliary Endoprosthesis: Deployment of GORE® VIABIL® Biliary Endoprosthesis to the area of stricture |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GORE VIABIL | GORE® VIABIL® Biliary Endoprosthesis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Safe Stent Removal | The stent removal is considered safe when the Study Device is removed successfully and without SAEs. | Subjects with stent removal data available | Posted | Count of Participants | Participants | Upon Removal |
|
|
Adverse events were collected for patients upto 12 Months of treatment period with the stent and upto 15 Months of post 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 | GORE VIABIL | GORE® VIABIL® Biliary Endoprosthesis | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Recurrence of obstructive jaundice | Hepatobiliary disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rizwan Afzal | W.L. Gore & Associates | 623-234-5408 | rafzal@wlgore.com |
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| Upon Implant |
| Successful Treatment of Benign Stricture Upon Implant | Successful treatment of strictures is defined as stricture resolution upon implant as reported by the PI. For the purpose of this report, we will be referring to this as "stented stricture resolution". | Upon implant |
| Secondary Patency | 12 Months |
| Viability of Treatment | Treatment is considered viable when the Study Device is removed and the structure is either resolved or improved without the need for re-stenting at the time of Study Device removal. | Upon Removal |
| Secondary Patency Post Study Device Removal | Secondary patency post study device removal is defined as the absence of stricture recurrence from time of Study Device removal to study completion or lost to follow up. Secondary Patency is also known as Long Term Stricture Resolution. | 15 Months |
| Primary Patency of Treated Stricture | Primary patency of the treated stricture is defined as freedom from stricture intervention due to occlusion following Study Device removal. | 15 Months |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Other Pre-specified | Primary Device Patency | Primary device patency is defined as the freedom from device occlusion requiring intervention (during the treatment period). | Posted | Number | 95% Confidence Interval | percentage of participants | 12 Months |
|
|
|
| Other Pre-specified | Successful Delivery and Deployment | This requires successful delivery and deployment of the device at the intended site. | Posted | Count of Participants | Participants | Upon Implant |
|
|
|
| Other Pre-specified | Successful Treatment of Benign Stricture Upon Implant | Successful treatment of strictures is defined as stricture resolution upon implant as reported by the PI. For the purpose of this report, we will be referring to this as "stented stricture resolution". | Posted | Number | participants | Upon implant |
|
|
|
| Other Pre-specified | Secondary Patency | Posted | Number | 95% Confidence Interval | percentage of participants | 12 Months |
|
|
|
| Other Pre-specified | Viability of Treatment | Treatment is considered viable when the Study Device is removed and the structure is either resolved or improved without the need for re-stenting at the time of Study Device removal. | Subjects with stent removal data available | Posted | Count of Participants | Participants | Upon Removal |
|
|
|
| Other Pre-specified | Secondary Patency Post Study Device Removal | Secondary patency post study device removal is defined as the absence of stricture recurrence from time of Study Device removal to study completion or lost to follow up. Secondary Patency is also known as Long Term Stricture Resolution. | Posted | Number | 95% Confidence Interval | percentage of participants | 15 Months |
|
|
|
| Other Pre-specified | Primary Patency of Treated Stricture | Primary patency of the treated stricture is defined as freedom from stricture intervention due to occlusion following Study Device removal. | Posted | Number | 95% Confidence Interval | percentage of participants | 15 Months |
|
|
|
| 36 |
| 19 |
| 36 |
| 6 |
| 36 |
| Pancreatitis | Hepatobiliary disorders | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
|
| Papillary hemorrhage | Hepatobiliary disorders | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | Non-systematic Assessment |
|
| Other | General disorders | Systematic Assessment |
|
Sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. Sponsor can require changes to the communication as necessary to ensure the proper use of any references to itself, its trademarks, and trade names and to correct inaccuracies in any technical specifications or descriptions of the device, including its component materials.