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

Launched by QUALIMED INNOVATIVE MEDIZINPRODUKTE GMBH · Jun 10, 2021

Keywords

ClinConnect Summary

The UNITY-B clinical trial is studying a new type of stent called the UNITY Balloon-Expandable Biodegradable Biliary Stent System. This stent is designed to help patients who have a condition called biliary stricture, where the bile ducts are blocked or narrowed. The main goal of the study is to check how safe this stent is for patients, while also looking at how well it works and whether it can improve the quality of life for those with biliary obstructions.

To be eligible for the trial, participants should be at least 18 years old and have a specific type of bile duct blockage, which can be due to various reasons such as benign or malignant conditions. People who are not able to follow up or have certain health issues may not be eligible. If someone joins the study, they can expect to receive the stent and be monitored closely for safety and effectiveness. This trial is currently recruiting participants, and it aims to gather important information that could help improve treatments for biliary stricture in the future.

Gender

ALL

Eligibility criteria

• 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.
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