Health Trials

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

ConditionsBiliary ObstructionBile Duct StrictureBile Duct Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorQualiMed Innovative Medizinprodukte GmbH

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Subject is unwilling to comply with the follow-up schedule

Life expectancy < 12 m,

Inability to pass a guidewire through stricture

Contra-indication for endoscopy or interventional radiology

Trial design

Treatments tested in this trial

  • Biliary Duct Stenting

Treatment groups

100 Participants
are divided into 1 treatment group

Locations

6
Hong Kong
Queen Mary Hospital Hong Kong Hong Kong
The Prince of Wales Hospital Hong Kong Hong Kong
India
AIG Hospitals (Asian Institute of Gastroenterology)500032, Hyderabad India
Malaysia
Sunway Medical Centre47500, Kuala Lumpur Malaysia

Sponsors and collaborators

QualiMed Innovative Medizinprodukte GmbH

Lead sponsor

Source ClinicalTrials.gov