Hot AXIOS™ for Bile Duct Drainage in Malignant Stenosis
NCT06750146 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162
Last updated 2026-05-22
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.
Conditions
- Malignant Biliary Stenosis
Interventions
- DEVICE
-
Hot AXIOS™ Stent and Electrocautery Enhanced Delivery System
The Hot AXIOS™ Stent and Electrocautery Enhanced Delivery System is commercially available and can be used to bridge two lumens or organs to create an internal drain, so as to drain the bile ducts in case of failure of ERCP.
Sponsors & Collaborators
-
Boston Scientific Corporation
lead INDUSTRY
Principal Investigators
-
Jean-Baptiste Chevaux · Central Hospital, Nancy, France
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-19
- Primary Completion
- 2027-05-31
- Completion
- 2027-05-31
Countries
- France
Study Locations
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