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OpenTrials
Completed

NCT Number: NCT01343160

Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures

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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Key information

Conditions

Biliary Strictures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Ludwigsburg

Ludwigsburg, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GORE® VIABIL® Biliary Endoprosthesis

Device

Deployment of GORE® VIABIL® Biliary Endoprosthesis to the area of stricture

Primary outcomes

  1. Safe Stent Removal

    Time frame: Upon Removal

    The stent removal is considered safe when the Study Device is removed successfully and without SAEs.

Other outcomes

  1. Primary Device Patency

    Time frame: 12 Months

    Primary device patency is defined as the freedom from device occlusion requiring intervention (during the treatment period).

  2. Successful Delivery and Deployment

    Time frame: Upon Implant

    This requires successful delivery and deployment of the device at the intended site.

  3. Successful Treatment of Benign Stricture Upon Implant

    Time frame: 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".

  4. Secondary Patency

    Time frame: 12 Months

  5. Viability of Treatment

    Time frame: 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.

  6. Secondary Patency Post Study Device Removal

    Time frame: 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.

  7. Primary Patency of Treated Stricture

    Time frame: 15 Months

    Primary patency of the treated stricture is defined as freedom from stricture intervention due to occlusion following Study Device removal.

Sponsors and collaborators

Lead sponsor

W.L.Gore & Associates

Industry

Registry information

Official study title

Multicenter Study of Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Apr 27, 2011
Registry last updated
Apr 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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