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Clinical Trials/NL-OMON31943
NL-OMON31943
Withdrawn
N/A

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

Alveolus, Inc.0 sites10 target enrollmentTBD
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ConditionsCBD obstructionmalignant biliary obstruction10018008

Overview

Phase
N/A
Intervention
Not specified
Conditions
CBD obstruction
Sponsor
Alveolus, Inc.
Enrollment
10
Status
Withdrawn
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Alveolus, Inc.

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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