Evaluation of the Safety and Effectiveness of the UNITY-B Biodegradable Balloon-Expandable Biliary Stent System for Treating Biliary Strictures

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the UNITY-B Biodegradable Balloon-Expandable Biliary Stent System in patients with biliary strictures causing symptoms such as jaundice, pruritus, pale stool, and tea-colored urine. This study is a prospective, multicenter, single-arm, open-label feasibility trial aiming to assess the safety of this new biodegradable stent compared to conventional plastic or metallic stents, which may have complications like difficult removability and tissue ingrowth. The study uses the UNITY-B stent system, which consists of a balloon-expandable biodegradable hybrid stent delivered via an over-the-wire balloon catheter. The stent is implanted endoscopically ERCP or percutaneously if anatomy is altered. The stent gradually degrades through hydrolysis, potentially reducing the need for removal procedures. The trial focuses on patients needing biliary drainage either due to obstruction or to maintain clinical status after previous stenting or drainage. Participants will be monitored for safety by tracking complications within 30 days after the procedure. Clinical success will be measured by normalizing bilirubin levels and symptom relief within 14 days. Technical and procedural success, quality of life improvements, and biodegradation of the stent will be assessed at multiple follow-up visits up to 365 days. These visits include imaging and self-assessment scores to evaluate the stents performance and patient outcomes over time.

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