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

Recruiting now · Not applicable

Conditions studied: Biliary Obstruction, Bile Duct Stricture, Bile Duct Diseases

In brief

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

Key facts

Study ID: NCT04929821
Run by: QualiMed Innovative Medizinprodukte GmbH
People needed: 100
Starts: 2017-10-16
Expected to finish: 2026-07-01
Last updated by the study team: 2026-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

1) A subject with a biliary stricture may be entered into the study with: at least one of the following:
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
Malignant Biliary stricture at least 1 cm distal to the hilum as well as periampullary hilar strictures not involving the papilla.
Neoplasm diagnosed on clinical and imaging findings
Post-ERCP pancreatitis
Obstructive jaundice with evidence of pruritus, tea color urine and pale stool
Abnormal Bilirubin rate or
A planned exchange of plastic stents previously placed for management of symptomatic biliary stricture or
A previous Percutaneous Transhepatic Biliary Drainage (PTBD) for management of symptomatic biliary stricture 2) Age ≥ 18 years old

You may not qualify if…

Patients, male or female, presenting with the following criteria may be included:
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
History of allergic reactions to one of the compounds of investigational product.
Subject is unable or refuses to give informed consent
Subject is pregnant or breastfeeding
Patient under tutorship
Currently participating in another trial before reaching first endpoint.
Pseudo Klatskin tumors (metastases in the liver hilum) and gallbladder carcinoma
Patient need additional biliary stenting with another device than the study device.

Where it is running

Queen Mary Hospital — Hong Kong, Hong Kong (enrolling)
AIG Hospitals (Asian Institute of Gastroenterology) — Hyderabad, India (enrolling)
Sunway Medical Centre — Kuala Lumpur, Malaysia (enrolling)
University Malaya Medical Centre (UMMC)Clinical Investigation Centre (CIC) — Kuala Lumpur, Malaysia (enrolling)
The Prince of Wales Hospital — Hong Kong, Hong Kong
Universityi Kebangsaan Malaysia (UKM) — Kuala Lumpur, Malaysia

Full record on ClinicalTrials.gov

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