Ireland
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Recruiting Not applicable

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

NCT04929821 · tracked via the Priya Life Science India tracker
Sponsor
QualiMed Innovative Medizinprodukte GmbH
Phase
Not applicable
Started
2017-10-16
Last updated
2026-06-17

Condition(s) studied

Biliary ObstructionBile Duct StrictureBile Duct Diseases

Investigational drug(s) / intervention(s)

Biliary Duct Stenting

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: Patients, male or female, presenting with the following criteria may be included: 1. Subject is unwilling to comply with the follow-up schedule 2. Life expectancy \< 12 m, 3. Inability to pass a guidewire through stricture 4. Contra-indication for endoscopy or interventional radiology 5. History of allergic reactions to one of the compounds of investigational product. 6. Subject is unable or refuses to give informed consent 7. Subject is pregnant or breastfeeding 8. Patient under tutorship 9. Currently participating in another trial before reaching first endpoint. 10. Pseudo Klatskin tumors (metastases in the liver hilum) and gallbladder carcinoma 11. Patient need additional biliary stenting with another device than the study device. \-

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)

FacilityCityRegionStatus
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
Official registry record

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