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

Completed

• Conditions: CBD obstruction; malignant CBD obstruction; 10018008

• Registration Number: NL-OMON35349
• Lead Sponsor: Merit Medical Systems

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 13

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. Prior bilairy metal stent
e Perforation of any duct within the biliary tree
f. Life expectancy of <90 days
g. Disease that is amenable to curative resection
h. INR > 1.5
i. Prior gastric bypass or biliroth type I or type II gastric resection

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The Primary endpoints of this trial will be as follows:<br /><br>a. Device safety, including assessments of stent related complications and<br /><br>overall complication rate comparable to clinical literature </p><br>