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(s) studied
Investigational drug(s) / intervention(s)
Biliary Duct Stenting: UNITY-B Balloon-expandable Biodegradable Biliary Stent deployment in obstructed biliary ducts.
Study summary
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
Eligibility
Primary outcome measure(s)
- Safety Complication Rate for the first 30days — 30 days
Total number of all complications is calculated as aggregate for the duration 30 days (day zero till day30 after index procedure). Two-sided 95% confidence intervals is constructed using exact (Clopper-Pearson) method.
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| Queen Mary Hospital | Hong Kong | Hong Kong | Recruiting |
| The Prince of Wales Hospital | Hong Kong | Hong Kong | Enrolling By Invitation |
| AIG Hospitals (Asian Institute of Gastroenterology) | Hyderabad | India | Recruiting |
| Sunway Medical Centre | Kuala Lumpur | Malaysia | Recruiting |
| Universityi Kebangsaan Malaysia (UKM) | Kuala Lumpur | Malaysia | Completed |
| University Malaya Medical Centre (UMMC)Clinical Investigation Centre (CIC) | Kuala Lumpur | Malaysia | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04929821 on ClinicalTrials.gov ↗ ← All trials in India