French Prospective Study on Biliary Tract Drainage Guided by Endoscopic Ultrasound in Patients With Malignant Biliary Stenosis (RAINBOW)
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients 18 years or older
• Willing and able to comply with study procedures and provide written informed consent
• Patients with failed ERCP for treatment of suspected malignant biliary obstruction
• Patients for whom an indication for Hot AXIOS™ stent placement has been determined
Locations
Other Locations
France
CHU de Besançon
NOT_YET_RECRUITING
Besançon
Clinique des Cedres, Ramsay Sante
RECRUITING
Cornebarrieu
CHU Limoges
NOT_YET_RECRUITING
Limoges
Hopital Prive Jean Mermoz
RECRUITING
Lyon
Clinique Jules Verne
RECRUITING
Nantes
CHU Nice
NOT_YET_RECRUITING
Nice
Hopital Europeen Georges-Pompidou
RECRUITING
Paris
Hopital Paris Saint-Joseph
RECRUITING
Paris
Hopital Saint Antoine
RECRUITING
Paris
CHU de Poitiers
NOT_YET_RECRUITING
Poitiers
CHU Reims
RECRUITING
Reims
CHRU Hopital Pontchaillou
RECRUITING
Rennes
Clinique Saint-Hilaire
RECRUITING
Rouen
Santé Atlantique
RECRUITING
Saint-herblain
CHU de Strasbourg
NOT_YET_RECRUITING
Strasbourg
CHU Rangueil
RECRUITING
Toulouse
CHRU de Nancy
RECRUITING
Vandœuvre-lès-nancy
Centre Hospitalier de Vichy
RECRUITING
Vichy
Contact Information
Primary
Katherine Stroud
katherine.stroud@bsci.com
617-233-5845
Backup
Pooja Goswamy
pooja.goswamy@bsci.com
508.683.4335
Time Frame
Start Date: 2025-06-19
Estimated Completion Date: 2027-05
Participants
Target number of participants: 162
Treatments
Experimental: Hot AXIOS™ Recipients
The Hot AXIOS™ Stent is a flexible, fully covered self-expanding metal stent that is preloaded within the Electrocautery Enhanced Delivery System. Patients who meet all eligibility criteria will receive the Hot AXIOS™stent and their quality of life will be measured at baseline, two weeks after stent placement and two months after stent placement by the jaundice dimension of the EORTC QLQ-BIL21 questionnaire. A patient is considered enrolled after signing the study-specific Informed Consent Form (ICF). Patients who sign the ICF but subsequently do not meet one or more of the selection criteria will be considered screen failures and excluded from the study.
Related Therapeutic Areas
Sponsors
Leads: Boston Scientific Corporation