Hot AXIOS® Prosthesis in Real Life Conditions -
REALAXIOS
Observational Study of Patients Treated With Hot AXIOS® Prosthesis in Real Life Conditions -
1 other identifier
observational
176
1 country
17
Brief Summary
Regulatory Context The CNEDiMTS makes the renewal of registration conditional on the transmission of the results of a well-conducted prospective study, carried out with Hot AXIOS, the objective of which is to evaluate the interest of this device in real conditions of use with regard to effectiveness and complications after a minimum follow-up of 3 months. Operators are trained in the use of the equipment (practice on ex-vivo model and/or prior stent placement) and undertake to comply with the rules and formalities of use. Primary efficacy objective : To evaluate the efficacy of endoscopic trans digestive drainage after use of the Hot AXIOS prosthesis in the treatment of pancreatic collections (incompletely fluid or necrotic) at 3 months. Secondary Objectives : Assessment of the following elements :
- 1.Morbidity (complication rates) and mortality per- and post-procedure
- 2.Recurrence rate of pancreatic collection
- 3.Evolution of the quality of life questionnaire (SQ5D5L)
- 4.Technical success rate of prosthesis placement and removal success rate of the prosthesis
- 5.Search for factors predictive of clinical success of endoscopic pancreatic drainage with the Hot Axios prosthesis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2021
Typical duration for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2021
CompletedFirst Posted
Study publicly available on registry
March 4, 2021
CompletedStudy Start
First participant enrolled
April 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 9, 2023
CompletedMay 17, 2024
May 1, 2024
2.6 years
March 1, 2021
May 16, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
patients with clinical success
reduction in the size of the pancreatic fluid collection ≤ 3 cm, evaluated by imaging
3 months
Secondary Outcomes (5)
Collect all complications,
3 months
recurrence of pancreatic collection
3 months
evolution of the quality of life questionnaire
3 months
Evaluate the technical success rate
3 months
Look for factors predictive of clinical success
3 months
Interventions
endoscopic trans digestive drainage using of the Hot AXIOS prosthesis in the treatment of pancreatic collections (incompletely fluid or necrotic)
Eligibility Criteria
patients having benefited from the treatment of pancreatic collections
You may qualify if:
- Should benefit from the installation of a Hot Axios system as part of PBDA support, regardless of the indication.
- Age ≥ 18 years old,
- Having signed his or her no objection or the trusted person if the patient is unable to do so prior to the procedure
- Affiliated to a social security scheme
You may not qualify if:
- Patients who have indicated that they do not wish to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Avignon Hospital
Avignon, 84000, France
brest Hospital
Brest, 29603, France
Clermont-ferrand hospital
Clermont-Ferrand, 63003, France
Polyclinique Saint Côme
Compiègne, 60204, France
Lille Hospital
Lille, 59037, France
Limoges hospital
Limoges, 87042, France
Clinique Jean Mermoz
Lyon, 69008, France
APHM
Marseille, 13000, France
European Hospital
Marseille, 13000, France
St Joseph Hospital
Marseille, 13000, France
Nancy Hospital
Nancy, France
Nice Hospital
Nice, 06000, France
APHP saint antoine
Paris, 75012, France
Hôpital privé des peupliers
Paris, 75013, France
Poitiers Hospital
Poitiers, 86021, France
Saint Etienne Hospital
Saint-Etienne, 42055, France
Centre Hospitalier Jacques Lacarin
Vichy, 03207, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2021
First Posted
March 4, 2021
Study Start
April 18, 2021
Primary Completion
November 9, 2023
Study Completion
November 9, 2023
Last Updated
May 17, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share