Clinical investigation of the safety and efficacy of ALIMAXX-B biliary stent for bile duct obstructio

Withdrawn

• Conditions: CBD obstruction; malignant biliary obstruction; 10018008

• Registration Number: NL-OMON31943
• Lead Sponsor: Alveolus, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

a. Malignant obstructive disease at the level of the extrahepatic CBD
b. Willing and able to comply with study procedures and provide written informed consent
c. > 18 years of age presenting with biliary obstruction

Exclusion Criteria

a. Benign obstruction of the CBD
b. Malignancy involving intrahepatic ducts or duodenum
c. Stricture >8cm in length
d. Inability to pass a guidewire through the stricture area
e. Prior biliary stent
f. Perforation of any duct within the biliary tree
g. Life expectancy of <90 days
h. Disease that is amenable to curative resection
i. INR > 1.5
j. Prior gastric bypass or biliroth type I or type II gastric resection

Study & Design

• Study Type: Interventional
• Study Design: Not specified