Biliary Strictures
Conditions
Brief summary
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.
Interventions
Deployment of GORE® VIABIL® Biliary Endoprosthesis to the area of stricture
Sponsors
W.L.Gore & Associates
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is diagnosed with treatable benign biliary stricture which necessitates the need for implantation of a biliary endoprosthesis * Subject is ≥18 years of age * Subject is able to comply with study protocol and follow-up requirements * Written informed consent is obtained using the Investigational Review Board (IRB)/Ethics Committee (EC) approved consent form
Exclusion criteria
* Subject anatomy ruling out covered self expanding metal stent use (e.g. above hilar region) * Treatment of stricture would require placement of a covered biliary endoprosthesis within a previously placed bare metal stent * The subject has malignant biliary disease * Subject has known pregnancy * Participated in protocol involving investigational drug or device within 90 days prior to entry into this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safe Stent Removal | Upon Removal | The stent removal is considered safe when the Study Device is removed successfully and without SAEs. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Successful Delivery and Deployment | Upon Implant | This requires successful delivery and deployment of the device at the intended site. |
| Successful Treatment of Benign Stricture Upon Implant | 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. |
| Secondary Patency | 12 Months | — |
| Primary Device Patency | 12 Months | Primary device patency is defined as the freedom from device occlusion requiring intervention (during the treatment period). |
| Secondary Patency Post Study Device Removal | 15 Months | 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. |
| Primary Patency of Treated Stricture | 15 Months | Primary patency of the treated stricture is defined as freedom from stricture intervention due to occlusion following Study Device removal. |
| Viability of Treatment | Upon Removal | 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. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GORE VIABIL GORE® VIABIL® Biliary Endoprosthesis | 36 |
| Total | 36 |
Baseline characteristics
| Characteristic | GORE VIABIL |
|---|---|
| Age, Continuous | 57.9 Years STANDARD_DEVIATION 12.7 |
| Region of Enrollment Belgium | 3 participants |
| Region of Enrollment Germany | 33 participants |
| Sex: Female, Male Female | 07 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 36 |
| other Total, other adverse events | 6 / 36 |
| serious Total, serious adverse events | 19 / 36 |
Outcome results
Primary
Safe Stent Removal
The stent removal is considered safe when the Study Device is removed successfully and without SAEs.
Time frame: Upon Removal
Population: Subjects with stent removal data available
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GORE VIABIL | Safe Stent Removal | 33 Participants |
Other Pre-specified
Primary Device Patency
Primary device patency is defined as the freedom from device occlusion requiring intervention (during the treatment period).
Time frame: 12 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE VIABIL | Primary Device Patency | 77.7 percentage of participants |
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.
Time frame: 15 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE VIABIL | Primary Patency of Treated Stricture | 64.8 percentage of participants |
Other Pre-specified
Secondary Patency
Time frame: 12 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE VIABIL | Secondary Patency | 84.3 percentage of participants |
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.
Time frame: 15 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE VIABIL | Secondary Patency Post Study Device Removal | 67.8 percentage of participants |
Other Pre-specified
Successful Delivery and Deployment
This requires successful delivery and deployment of the device at the intended site.
Time frame: Upon Implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GORE VIABIL | Successful Delivery and Deployment | 36 Participants |
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.
Time frame: Upon implant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE VIABIL | Successful Treatment of Benign Stricture Upon Implant | 35 participants |
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.
Time frame: Upon Removal
Population: Subjects with stent removal data available
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GORE VIABIL | Viability of Treatment | 26 Participants |