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SUSPENDED
NCT06750146
NA

Hot AXIOS™ for Bile Duct Drainage in Malignant Stenosis

Sponsor: Boston Scientific Corporation

View on ClinicalTrials.gov

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.

Official title: French Prospective Study on Biliary Tract Drainage Guided by Endoscopic Ultrasound in Patients With Malignant Biliary Stenosis (RAINBOW)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

162

Start Date

2025-06-19

Completion Date

2027-05

Last Updated

2026-06-23

Healthy Volunteers

No

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.

Locations (18)

CHU de Besançon

Besançon, France

Clinique des Cedres, Ramsay Sante

Cornebarrieu, France

CHU Limoges

Limoges, France

Hopital Prive Jean Mermoz

Lyon, France

Clinique Jules Verne

Nantes, France

CHU Nice

Nice, France

Hopital Saint Antoine

Paris, France

Hopital Paris Saint-Joseph

Paris, France

Hopital Europeen Georges-Pompidou

Paris, France

CHU de Poitiers

Poitiers, France

CHU Reims

Reims, France

CHRU Hopital Pontchaillou

Rennes, France

Clinique Saint-Hilaire

Rouen, France

Santé Atlantique

Saint-Herblain, France

CHU de Strasbourg

Strasbourg, France

CHU Rangueil

Toulouse, France

CHRU de Nancy

Vandœuvre-lès-Nancy, France

Centre Hospitalier de Vichy

Vichy, France