Phase 3 N=187 WallFlex Biliary Fully Covered (FC) Benign Stricture Study
Biliary Stricture
Primary: Stent Removability — 132 Participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=129 A Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures
Inoperable Tumors of the Bile Duct
Primary: Time to Recurrent Biliary Obstruction — 711; 357 days — p=0.530
N/A N=23 Evaluation of the Use of Metal Stents as Part of the Treatment of Benign Biliary Strictures
Benign Biliary Strictures
Primary: Short Term Success Rate in the Resolution of Biliary Strictures — 22; 14; 3; 5 participants
N/A N=112 Covered Metallic Stents for First-Line Treatment of Benign Bile Duct Strictures
Common Bile Duct Stricture
Primary: Early Clinical Success — 50; 41 Participants
N/A N=7 Optical Frequency Domain Imaging (OFDI) for Biliary Stricture Imaging
Biliary Stricture
Primary: Feasibility of Imaging the Bile Duct With the OFDI Probe — 7 Participants
N/A N=36 Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures
Biliary Strictures
Primary: Safe Stent Removal — 33 Participants
N/A N=23 Prospective Evaluation of Winged Biliary Stent Patency in Patients With Benign Biliary Obstruction
Biliary Stricture
Primary: Count of Participants With Stent Patency at 90 Days — 22 Participants
N/A N=10 WallFlex Biliary Post Liver Transplant IDE Pilot
Anastomotic Biliary Stricture Post Orthotopic Liver Transplant
Primary: Stricture Resolution at the Time of Stent Removal. — 9; 1 participants
N/A N=70 Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
Biliary Strictures Caused by Malignant Neoplasms
Primary: Number of Participants With Absence of Recurrent Biliary Obstruction — 62 Participants
Phase 3 N=74 A Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
Cholestasis, Extrahepatic
Primary: Adequate Clinical Palliation of the Biliary Obstruction — 54 participants
N/A N=164 WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis Study
Biliary Stricture
Primary: Number of Participants With Stricture Resolution — 47; 54 Participants — p=.008
N/A N=7 Evaluation of Pancreatobiliary Disorders in Patients With Altered Gastric Anatomy
Pancreatobiliary Disease · Altered Gastric Anatomy
Primary: Papilla or Duct-enterostomy Was Reached — 10 ERCPs
N/A N=63 Plastic vs. Covered Metal vs. Uncovered Metal Biliary Stents for the Management of Malignant Biliary Obstruction
Pancreatic Cancer
Primary: Assess the Occlusion Rates, Attempted Surgical Resection or Death of Plastic, Covered, and Uncovered Biliary Stents in Patients Presenting With Malignant Biliary…
N/A N=284 Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer
Pancreatic Carcinoma
Primary: Number of Serious Pre-operative, Operative and Post-operative Adverse Events to 120 Days Post Randomization or to 30 Days Post Surgery, Whichever Comes Last — 40; 36…
N/A N=211 Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers
Periampullary Cancers With Obstructive Jaundice · Pancreas Head Cancer · Bile Duct Cancer
Primary: Incidence of Infectious Complications After Biliary Drainage — 11; 5 participants
N/A N=115 Study to Compare the Incidence of Biliary Complications After Liver Transplantation
Liver Transplant; Complications
Primary: Number of Participants With Biliary Complications — 19; 12 participants
N/A N=18 WallFlex Esophageal Fully Covered (FC) Benign Anastomotic Stricture
Refractory Anastomotic Esophageal Strictures
Primary: Number of Dilation Procedures — 5.4; 2.4 Dilation procedures — p=0.159
Phase 2 N=90 Prospective Evaluation of Budesonide for Prevention of Esophageal Strictures After Endotherapy
Esophageal Stricture
Primary: Dysplasia in Barrett Esophagus (BE) — 4; 4; 3; 23 Participants — p=0.992
Phase 4 N=108 Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Hilar Cholangiocarcinoma
Hilar Cholangiocarcinoma
Primary: Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(ITT Analysis) — .7037037; .46296 proportion of participants — p=0.011
N/A N=17 Comparison of Duodenal Stenting vs Transpyloric and Duodenal Stenting for Malignant Obstruction
Duodenal Obstruction
Primary: Number of Participants With Any Change (2 Point Increase or Decrease) in Symptoms From Baseline — 7; 6 Participants
Phase 3 N=24 Endoscopic Biliary Co-axial Stent Placement Plus/Minus Use of Radiofrequency Ablation (RFA) for Clearance of Occluded Self Expandable Metal Stents (SEMS) in Patients With Distal Biliary Obstruction From Unresectable Biliary-pancreatic Malignancies
Pancreatic Cancer · Unresectable Biliary-pancreatic Malignancies
Primary: Rate of Failure
N/A N=75 The Clinical Utility of Cholangioscopy and Pancreatoscopy in the Diagnosis and Management of Pancreaticobiliary Disorders
Disorders of the Pancreas and Biliary Tree
Primary: Successful Procedure Completion — 70; 5 participants
N/A N=197 Pancreaticobiliary Reflux in Patients Without Cholelithiasis
Pancreaticobiliary Reflux
Primary: Amylase and Lipase Values in Gallbladder Bile — 5.5; 181.2; 9.5; 434.8 mg/dl
N/A N=6 Covered vs Uncovered Metal Stents for Palliative Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction
Distal Bile Duct Obstruction
Primary: Rate of Long-term Stent Failure — 0; 2 Participants
N/A N=67 WallFlex Pancreatic Metal Stent for Pancreatic Duct Strictures
Chronic Pancreatitis
Primary: Pain Reduction — 12 Participants — p=0.999
N/A N=26 Outcomes of Esophageal Self Dilation for Benign Refractory Esophageal Stricture Management
Esophageal Dilation · Refractory Benign Esophageal Stricture
Primary: Number of Endoscopic Interventions — 12; 11; 12; 7 endoscopies
N/A N=119 Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy
Pancreatic Cancer
Primary: Sustained Biliary Drainage, Defined as Absence of Reinterventions for the Management of Biliary Obstructive Symptoms — 39; 43 Participants — p=<0.01
Phase 2 N=13 N-Acetylcysteine in Biliary Atresia After Kasai Portoenterostomy
Biliary Atresia
Primary: Number of Patients With Biliary Atresia (BA) Achieving Total Serum Bile Acids Less Than or Equal to 10 *U*Mol/L Within 24 Weeks of Kasai Portoenterostomy (KP) — 0…
N/A N=66 Angled-tip vs. Straight-tip Guidewire in Biliary Cannulation
Bile Duct Diseases
Primary: Cannulation — 30; 31 Participants
N/A N=30 AXIOS™ for Gallbladder Drainage as an Alternative to Percutaneous Drainage IDE
Cholecystitis, Acute
Primary: Number of Days to Resolution of Acute Cholecystitis — 5.30 days