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Study identifier: NCT04929821 Synced from ClinicalTrials.gov · July 29, 2026
● 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

Condition: Biliary Obstruction · Bile Duct Stricture · Bile Duct Diseases  ·  Sponsor: QualiMed Innovative Medizinprodukte GmbH

PhaseNA
Planned participants100
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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

This description comes directly from the study's public registry record.

Talk to the study team

Hairol Azrin bin Othman, MD  ·  60374919191  ·  hairol@gmail.com

Edwin Tan  ·  60374911226  ·  edwinbt@sunway.com.my

Always discuss trial participation with your own doctor first.

Locations (6)

Queen Mary HospitalHong Kong, Hong KongRecruiting
The Prince of Wales HospitalHong Kong, Hong KongEnrolling By Invitation
AIG Hospitals (Asian Institute of Gastroenterology)Hyderabad, IndiaRecruiting
Sunway Medical CentreKuala Lumpur, MalaysiaRecruiting
Universityi Kebangsaan Malaysia (UKM)Kuala Lumpur, MalaysiaCompleted
University Malaya Medical Centre (UMMC)Clinical Investigation Centre (CIC)Kuala Lumpur, MalaysiaRecruiting

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Source record: clinicaltrials.gov/study/NCT04929821