Informations générales (source: ClinicalTrials.gov)
French Prospective Study on Biliary Tract Drainage Guided by Endoscopic Ultrasound in Patients With Malignant Biliary Stenosis (RAINBOW) (RAINBOW)
Interventional
N/A
Boston Scientific Corporation (Voir sur ClinicalTrials)
juin 2025
mai 2027
12 juillet 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Europeen Georges Pompidou | Enrique Pérez-Cuadrado Robles | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Saint Antoine | Tamazouzt Nait Saada | Contact (sur clinicalTrials) | |||
| GH PARIS SITE SAINT JOSEPH | Yasmine Bouaraba | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier de Vichy - 03200 - Vichy - France | Aurélien Piraud | Contact (sur clinicalTrials) | |||
| CHRU de Nancy - 54500 - Vandœuvre-lès-Nancy - France | Guillaume Fouquet | Contact (sur clinicalTrials) | |||
| CHRU Hopital Pontchaillou - 35033 - Rennes - France | Enora Ouamara-Digue | Contact (sur clinicalTrials) | |||
| CHU de Besançon - 25030 - Besançon - France | Fanny Vaurie | Contact (sur clinicalTrials) | |||
| CHU de Poitiers - 86021 - Poitiers - France | Laetitia Rouleau | Contact (sur clinicalTrials) | |||
| CHU de Strasbourg - 67091 - Strasbourg - France | Pauline Simo-Noumbissie | Contact (sur clinicalTrials) | |||
| CHU Limoges - 87042 - Limoges - France | Sandrine Nlend | Contact (sur clinicalTrials) | |||
| CHU Nice - 06202 - Nice - France | Nadège Bouskila | Contact (sur clinicalTrials) | |||
| CHU Rangueil - 31059 - Toulouse - France | Adrien Pons | Contact (sur clinicalTrials) | |||
| CHU Reims - 51092 - Reims - France | Thomas Feron | Contact (sur clinicalTrials) | |||
| Clinique des Cedres, Ramsay Sante - 31700 - Cornebarrieu - France | Laure Combes | Contact (sur clinicalTrials) | |||
| Clinique Jules Verne - 44300 - Nantes - France | Elise Kerdreux | Contact (sur clinicalTrials) | |||
| Clinique Saint-Hilaire - 76000 - Rouen - France | Francoise Hupel | Contact (sur clinicalTrials) | |||
| Hopital Prive Jean Mermoz - 69008 - Lyon - France | Solene Piegay | Contact (sur clinicalTrials) | |||
| Santé Atlantique - 44800 - Saint Herblain - France | Vincent Wyart | Contact (sur clinicalTrials) | |||
Critères
Tous
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 malignant biliary obstruction
4. Patients for whom an indication for Hot AXIOS™ stent placement has been determined
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 malignant biliary obstruction
4. Patients for whom an indication for Hot AXIOS™ stent placement has been determined
1. Women who are pregnant, nursing or planning to become pregnant during the study
2. Patients with immediately resectable tumor
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