Clinical trials: Biliary Stricture
Biliary Strictures Caused by Malignant Neoplasms
Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
This is a a prospective study of the WallFlex™ Biliary Partially-covered Stent designed to collect data to support regulatory clearance by the FDA in the United States and to determine the functionality of the WallFlex™ Biliary…
- Trial name
- NCT00713427
- Testing
- WallFlex™ Biliary Partially-Covered Stent
- Where
- 6 sites in Belgium, France and 4 more
- Volunteers
- 70 people
- Sponsor
- Boston Scientific Corporation
Biliary Stricture, Malignant Neoplasms
Patency and Safety of the Drug Eluting Covered Biliary Stent Comparing to the Common Covered Biliary Stent
Paclitaxel covered metal biliary stent extents their patency rate comparing to the Common Covered Metallic Biliary Stent.
- Trial name
- MIRA-cover (NCT01512563)
- Testing
- Biliary stent
- Where
- 3 sites in South Korea
- Volunteers
- 106 people
- Sponsor
- Taewoong Medical Co., Ltd.
Biliary Stricture, Biliary Obstruction Due to Common Bile Duct Stone
SpyGlass AMEA Registry
The purpose of this study is to document indications for cholangioscopy and clinical utility of the SpyGlass Direct Visualization System (DVS) throughout the AMEA (Asia, Middle-East, Africa) region when used per standard of…
- Conditions
- Biliary Stricture, Biliary Obstruction Due to Common Bile Duct Stone, Periampullary Tumor, Hemobilia
- Trial name
- NCT02281019
- Testing
- ERCP (Endoscopic Retrograde Cholangiopancreatography), SpyGlass DVS and SpyGlass Digital Simple (DS)
- Where
- 20 sites in Australia, Hong Kong and 8 more
- Volunteers
- 526 people
- Sponsor
- Boston Scientific Corporation
Biliary Obstruction, Bile Duct Stricture
UNITY-B A Prospective, Multicentric, Single-arm Study to Evaluate the Safety and Efficacy of the UNITY-B Biodegradable Balloon-Expandable Biliary Stent System in Subjects With Biliary Strictures
STUDY TYPE: Feasibility study STUDY DESIGN: Prospective, multicenter, single-arm, open-label PRIMARY OBJECTIVE The primary objective is to assess safety of the UNITY Balloon-expandable Biodegradable Biliary Stent System SECONDARY…
- Conditions
- Biliary Obstruction, Bile Duct Stricture, Bile Duct Diseases
- Trial name
- NCT04929821
- Testing
- Biliary Duct Stenting
- Where
- 6 sites in Hong Kong, India and 1 more
- Volunteers
- 100 people
- Sponsor
- QualiMed Innovative Medizinprodukte GmbH
Biliary Strictures Caused by Malignant Neoplasms
The HANAROSTENT® Multi-Hole™ Biliary Stent is Indicated for Use in the Palliative Treatment of Biliary Strictures Produced by Malignant Neoplasms and the Study is to Demonstrate Clinical Safety and Performance of the Multi-Hole™ Stent for the Palliative Treatment of Malignant Biliary Obstruction.
The objective of this study is to demonstrate clinical safety and performance of the HANAROSTENT® Multi-Hole™ Biliary Stent for the palliative treatment of malignant biliary obstruction.
- Trial name
- NCT07715240
- Testing
- Biliary Stent for the Palliative Treatment of Malignant Biliary Obstruction
- Volunteers
- 66 people
- Sponsor
- Olympus Corporation of the Americas
Biliary Strictures
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.
- Trial name
- NCT01343160
- Testing
- GORE® VIABIL® Biliary Endoprosthesis
- Where
- Germany
- Volunteers
- 43 people
- Sponsor
- W.L.Gore & Associates
Biliary Stricture
WallFlex Biliary Fully Covered (FC) Benign Stricture Study
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.
- Trial name
- NCT01014390
- Testing
- WallFlex Biliary RX Fully Covered Stent System
- Where
- 13 sites in Australia, Austria and 9 more
- Volunteers
- 187 people
- Sponsor
- Boston Scientific Corporation
Primary Biliary Cholangitis, Primary Biliary Cirrhosis
Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis
The purpose of this open-label study is to evaluate the safety and tolerability of HDT1801 (BUDCA) over 12 weeks in adult subjects with PBC who have an inadequate response to standard therapy.
- Conditions
- Primary Biliary Cholangitis, Primary Biliary Cirrhosis, Cholangitis, Cholestasis
- Trial name
- PRONTO-PBC (NCT04604652)
- Testing
- HTD1801 (BUDCA)
- Where
- 12 sites in United States
- Volunteers
- 24 people
- Sponsor
- HighTide Therapeutics (Hong Kong) Limited
Biliary Strictures
Prospective, Multi-Center All-Comer Biliary Canadian WallFlex Registry
The purpose of this study is to document stent functionality and practice patterns in Canada pertaining to indications for use and stent type selection for self-expanding biliary metal stents (SEMS) when used per standard of…
- Trial name
- NCT02261623
- Testing
- WallFlex™ Biliary RX Fully Covered Stent System RMV, WallFlex™ Biliary RX Partially Covered Stent System, WallFlex™ Biliary RX Uncovered Stent System
- Where
- 12 sites in Canada
- Volunteers
- 415 people
- Sponsor
- Boston Scientific Corporation
Biliary Stricture, Malignant Neoplasms
Efficacy and Safety of the Paclitaxel Eluting Covered Biliary Stent to the Common Covered Metallic Biliary Stent
Paclitaxel covered metal biliary stent is non-inferior to common covered metal biliary stent in their patency rate and safety at the 6 months after stenting.
- Trial name
- MIRAII (NCT01413386)
- Testing
- biliary stent
- Where
- 3 sites in South Korea
- Volunteers
- 74 people
- Sponsor
- Jong Taek, Lee
Biliary Stricture, Biliary Anastomotic Stenosis
DIGEST I Drug Coated Balloon for Biliary Stricture
DIGEST I Pilot study is a feasibility study for evaluating the safety and efficacy of DCBs.
- Conditions
- Biliary Stricture, Biliary Anastomotic Stenosis, Biliary Obstruction, Biliary Disease
- Trial name
- DIGEST (NCT03997994)
- Testing
- GIE Drug Coated Balloon
- Where
- Paraguay
- Volunteers
- 8 people
- Sponsor
- GIE Medical
Pancreatitis, Chronic, Stricture; Bile Duct
GORE® VIABIL® Biliary Endoprosthesis in the Treatment of Benign Biliary Strictures Secondary to Chronic Pancreatitis
This study will evaluate the safety and effectiveness of the GORE® VIABIL® Biliary Endoprosthesis in the treatment of benign biliary strictures secondary to Chronic Pancreatitis (CP).
- Trial name
- VIABILITY (NCT05820009)
- Testing
- GORE® VIABIL® Biliary Endoprosthesis, GORE® VIABIL® Short Wire Biliary Endoprosthesis
- Where
- 2 sites in United States
- Volunteers
- 133 people
- Sponsor
- W.L.Gore & Associates
Biliary Stricture
WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis Study
The purpose of this of this study is to compare the use of Self Expanding Metal Stents (SEMS) to plastic stents for the treatment of benign biliary strictures secondary to chronic pancreatitis as it pertains to stricture…
- Trial name
- NCT01543256
- Testing
- WallFlex™ Biliary RX Fully Covered Stent System RMV, Commercially available Plastic Stent Per Investigator preference
- Where
- 14 sites in Australia, Austria and 9 more
- Volunteers
- 172 people, healthy volunteers welcome
- Sponsor
- Boston Scientific Corporation
Biliary Tract Cancer
X-MAS Biliary Study With Covered Biliary Stent
The purpose of this study is to provide safety and efficacy data for the X-Suit NIR® Covered Biliary Metallic Stent for subjects with malignant stricture(s) in the biliary tree.
- Trial name
- NCT01899976
- Testing
- X-Suit NIR Covered Biliary Stent
- Where
- 9 sites in Belgium, Israel and 1 more
- Volunteers
- 68 people
- Sponsor
- Medinol Ltd.
Anastomotic Biliary Stricture Post Orthotopic Liver Transplant
WallFlex Biliary Post Liver Transplant IDE Pilot
The primary objective of this study is to demonstrate effectiveness of the WallFlex Biliary RX Fully Covered Stent for anastomotic biliary strictures in post-orthotopic liver transplant (OLT) patients.
- Trial name
- NCT01151280
- Testing
- WallFlex Biliary Fully Covered Stent
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Boston Scientific Corporation
Pancreatic Cancer, Bile Duct Cancer
A Registry of Patients Undergoing Cellvizio Endomicroscopy and Endoscopic Retrograde Cholangiopancreatography(ERCP) Imaging Procedures for Diagnosing Pancreatic and Bile Duct Cancers
This registry will collect data from patients routinely undergoing an ERCP and Cellvizio endomicroscopy procedure (and optionally an additional cholangiopancreatoscopy procedure) due to suspected pancreatic or bile duct cancer.
- Trial name
- NCT00779688
- Testing
- Probe-based confocal laser endomicroscopy
- Where
- 6 sites in United States, France and 1 more
- Volunteers
- 130 people
- Sponsor
- Mauna Kea Technologies
Cholangiocarcinoma, Bile Duct Inflammation
pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture
This study will collect data from patients undergoing an ERCP procedure with probe-based Confocal Laser Endomicroscopy for suspicion of bile duct cancer.
- Trial name
- FOCUS (NCT01392274)
- Where
- 6 sites in United States, France and 1 more
- Volunteers
- 121 people
- Sponsor
- Mauna Kea Technologies
Malignant Biliary Stenosis
Hot AXIOS™ for Bile Duct Drainage in Malignant Stenosis
The study is designed to highlight the effectiveness of the Hot AXIOS™ stent when used in accordance with standard medical practice on the evolution of the quality of life of patients with malignant biliary stenosis requiring…
- Trial name
- RAINBOW (NCT06750146)
- Testing
- Hot AXIOS™ Stent and Electrocautery Enhanced Delivery System
- Where
- 18 sites in France
- Volunteers
- 162 people
- Sponsor
- Boston Scientific Corporation