Status: Recruiting
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
Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: QualiMed Innovative Medizinprodukte GmbHUpdated: Jun 17, 2026Locations: 6
Eligibility criteria
Benign fibrotic distal bile duct obstruction [+10]
Subject is unwilling to comply with the follow-up schedule [+10]