Clinical trials: Biliary Stents
Carcinomas/Neoplasms
Evolution® Biliary Stent System-Fully Covered
The Evolution® Biliary Stent System-Fully Covered study is a clinical trial approved by the US FDA to evaluate the effectiveness of the Evolution® Biliary Stent System-Fully Covered when used in palliation of malignant neoplasms…
- Trial name
- NCT02104076
- Testing
- Evolution® Biliary Stent-Fully Covered
- Where
- 12 sites in United States, Canada and 2 more
- Volunteers
- 90 people
- Sponsor
- Cook Group Incorporated
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 Tract Neoplasms, Neoplasms
Evolution® Biliary Stent System Clinical Study
The Evolution® Biliary Stent System Clinical Study is a clinical trial on a commercially available device to gather physician experience with the Cook Evolution® Biliary Stent System for the palliation of cancer in the biliary…
- Conditions
- Biliary Tract Neoplasms, Neoplasms, Gastrointestinal Diseases, Digestive System Diseases
- Trial name
- NCT01962168
- Testing
- Evolution® Biliary Stent - Uncovered
- Where
- 9 sites in United States, Canada
- Volunteers
- 113 people
- Sponsor
- Cook Group Incorporated
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
Malignant Obstruction of the Common Bile Duct
Clinical Feasibility Study of Allium's Biliary Stent
The purpose of this study is to evaluate the safety and efficacy of the Allium Biliary Stent in malignant obstructions of the common bile duct.
- Trial name
- NCT00448006
- Testing
- Allium Biliary Stent
- Where
- Israel
- Sponsor
- Allium, Ltd.
Biliary Tract Neoplasms, Pancreatic Neoplasms
Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)
This study compares the 6 mm nitinol Zilver biliary endoprostheses and the 10 mm nitinol Zilver biliary endoprostheses to the 10 mm Wallstent in appropriate patients in need of palliative treatment of malignant obstructive…
- Conditions
- Biliary Tract Neoplasms, Pancreatic Neoplasms, Jaundice, Obstructive
- Trial name
- NCT00196105
- Testing
- 6 mm Nitinol Zilver Stent, 10 mm Nitinol Zilver Stent, 10 mm Stainless Steel Wallstent
- Where
- United States
- Volunteers
- 241 people
- Sponsor
- Cook Group Incorporated
Pancreatic Carcinoma
Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer
The purpose of this study is to demonstrate that preoperative biliary drainage using self-expanding metal stents (SEMS) does not negatively impact overall surgical outcomes in patients undergoing pancreaticoduodenectomy for…
- Trial name
- NCT01774019
- Testing
- WallFlex™ Biliary RX Fully Covered/Uncovered Stent System
- Where
- 11 sites in United States, Australia and 7 more
- Volunteers
- 284 people
- Sponsor
- Boston Scientific Corporation
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
Hilar Cholangiocarcinoma
Efficacy and Safety Study of PDT Using Photofrin in Unresectable Advanced Perihilar Cholangiocarcinoma (OPUS)
Photodynamic therapy (PDT) is a combination of a drug, porfimer sodium (Photofrin), which is activated by a light from a laser that emits no heat.
- Trial name
- NCT02082522
- Testing
- Photodynamic therapy-Photofrin, Stenting procedure, Chemotherapy regimen
- Where
- 31 sites in United States, Canada and 3 more
- Volunteers
- 28 people
- Sponsor
- Concordia Laboratories Inc.
Cholestasis, Extrahepatic
A Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
The overall objective of this study is to assess the functionality of the WallFlex™ Biliary Fully-covered stent as a palliative treatment for malignant bile duct obstruction.
- Trial name
- NCT00433771
- Testing
- WallFlex™ Biliary Fully Covered Metal Stent placement
- Where
- 10 sites in United States
- Volunteers
- 74 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
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
Obstructed Biliary and Pancreatic Duct
To Evaluate the Safety and Clinical Performance of the ARCHIMEDES Biodegradable Biliary and Pancreatic Stent
Significant experience with biodegradable materials has been reported in the orthopedic literature; in particular; biodegradable stents have been used in the endovascular and urologic epithelium.
- Trial name
- Registry (NCT04708288)
- Testing
- ARCHIMEDES Biodegradable Biliary and Pancreatic Stent
- Where
- 11 sites in Finland, France and 6 more
- Volunteers
- 198 people
- Sponsor
- QualiMed Innovative Medizinprodukte GmbH
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
Cancer of Bile Duct, Pancreatic Cancer
Comparing Covered Self-expandable Metallic Stent (SEMS) Above/Across the Sphincter of Oddi
The purpose of this prospective, randomized multicenter study is to determine whether there is any difference in stent patency of covered metallic stents in terms of stent positioning, above and across the sphincter of Oddi, in…
- Trial name
- NCT01041612
- Testing
- PTFE Covered ComVi [full covered] Biliary Stent
- Where
- 13 sites in Japan, South Korea
- Volunteers
- 120 people
- Sponsor
- Taewoong Medical Co., Ltd.
Pancreatic Cancer
Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy
The purpose of this study is to demonstrate non-inferiority of Fully Covered biliary SEMS to Uncovered biliary SEMS in biliary drainage for the pre-operative management of biliary obstructive symptoms caused by pancreatic cancer…
- Trial name
- NCT02238847
- Testing
- WallFlex™ Biliary RX Fully Covered/Uncovered Stent System
- Where
- 9 sites in United States, Belgium and 4 more
- Volunteers
- 119 people
- 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.
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 Neoplasms, Biliary Obstruction
Comparison of Drug Eluting Stent and Covered Metal Stent in Malignant Biliary Obstruction (MIRA III)
The purpose of this study is to compare the effectiveness and safety of Niti-S Mira-Cover III Biliary Stent with Comvi Biliary Covered Stent for the treatment of malignant biliary obstruction.
- Conditions
- Biliary Neoplasms, Biliary Obstruction, Pancreatic Neoplasms
- Trial name
- NCT02460432
- Testing
- Paclitaxel-eluting metal Stent, Covered Metal Stent
- Where
- 5 sites in South Korea
- Volunteers
- 106 people
- Sponsor
- Taewoong Medical Co., Ltd.
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