Hot AXIOS™ for Bile Duct Drainage in Malignant Stenosis
NCT ID: NCT06750146
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
SUSPENDED
NA
162 participants
INTERVENTIONAL
2025-06-19
2027-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
AXIOS™ for Gallbladder Drainage as an Alternative to Percutaneous Drainage IDE
NCT03767881
French Assessment of the Relay Plus and Relay NBS Plus Thoracic Stent-Graft
NCT05030740
Korean Multicenter Registry of EPIC Stent for Iliac Artery Disease: (K-EPIC Registry)
NCT02698358
Medical & Economical Evaluation of Fenestrated & Branched Stent-grafts to Treat Complex Aortic Aneurysms
NCT01168037
AXIOS Stent With Electrocautery Enhanced Delivery System
NCT02146352
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boston Scientific Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jean-Baptiste Chevaux
Role: PRINCIPAL_INVESTIGATOR
Central Hospital, Nancy, France
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
E7209
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.