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Suspended
NCT06750146
Hot AXIOS™ for Bile Duct Drainage in Malignant Stenosis
Conditions: Malignant Biliary Stenosis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 162
Sponsor: Boston Scientific Corporation
Location: CHU de Besançon Besançon
Summary
The study is designed to highlight the effectiveness of the Hot AXIOS™ stent when used in accordance with standard medical practice on the evolution of the quality of life of patients with malignant biliary stenosis requiring drainage of the bile ducts after failure of ERCP, in the two months after stent placement.
Eligibility Criteria
Inclusion Criteria:
1. Patients 18 years or older
2. Willing and able to comply with study procedures and provide written informed consent
3. Patients with failed ERCP for treatment of suspected malignant biliary obstruction
4. Patients for whom an indication for Hot AXIOS™ stent placement has been determined
Exclusion Criteria:
1. Women who are pregnant, nursing or planning to become pregnant during the study
2. Patients with immediately resectable tumor or resectable during the two months of the study
3. Patients for whom the placement of a double pigtail prosthesis is planned by the investigator during the index procedure
4. Current participation in another investigation drug or device study that could interfere with the endpoints of this study
5. Persons under guardianship or curatorship
Source: ClinicalTrials.gov (NCT06750146). StuddyBuddy aggregates publicly available trial information.