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 OBJECTIVES Clinical /Technical /Procedural success, Quality of Life improvement, biodegradation rate
• 1\) A subject with a biliary stricture may be entered into the study with: at least one of the following:
• Benign fibrotic distal bile duct obstruction
• Duct occlusion caused by cholelithiasis
• A benign fibrotic distal obstruction of the Common Bile Duct (CBD), demonstrated by presence of a stenosis on magnetic resonance cholangiopancreatography (MRCP) and/or ERCP with proximal ductal dilation and cholestatic liver enzymes levels
• Ductal anastomotic strictures
• Malignant Biliary stricture at least 1 cm distal to the hilum as well as periampullary hilar strictures not involving the papilla.
• Neoplasm diagnosed on clinical and imaging findings
• Post-ERCP pancreatitis
• Obstructive jaundice with evidence of pruritus, tea color urine and pale stool
• Abnormal Bilirubin rate or
• A planned exchange of plastic stents previously placed for management of symptomatic biliary stricture or
• A previous Percutaneous Transhepatic Biliary Drainage (PTBD) for management of symptomatic biliary stricture 2) Age ≥ 18 years old