Hot AXIOS® Prosthesis in Real Life Conditions -
Sponsored by Centre Hospitalier Universitaire de Nice
About this trial
Last updated 3 years ago
Study ID
19-PP-20
Status
Recruiting
Type
Observational
Placebo
No
Accepting
18+ Years
All
Trial Timing
Ended 2 years ago
What is this trial about?
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.
Study design Non-interventional/observational (RIPH 3 type), multi-center, prospective study
with consecutive inclusions evaluating the Hot AXIOS® prosthetic device.
Non-inclusion registry A minimum amount of information will be collected anonymously,
including sex, age, indication of drainage and reason for non-inclusion (e.g. refusal of the
patient, of the investigator for impossibility of following the patient in the centre or
other reasons to be specified). Generic information will be affixed in each centre
participating in the study indicating: "In application of the provisions of the Data
Protection Act, general information on the possibility that personal data may be used for
research purposes must be provided in any establishment or centre where prevention, diagnosis
and care activities are carried out". This must be exhaustive and rigorously maintained.
Equipment used in endoscopy Hot AXIOS™ - self-expanding metal prosthesis with a lumen
diameter of 6 to 20 mm and collar length of 8 and 10 mm or any future similar device marketed
under the same name at the time of the study.
Technique Insertion of the material under echo-endoscopic control -- possible but not
systematic dilatation -- guide wire with hydrophilic tip - Puncture and release under
echo-endoscopic control according to the centre's usual practice.
Registration The data will be collected anonymously in an electronic computer database using
eCRFs.
Statistical analysis The evaluation of the clinical success of endoscopic pancreatic
necrosectomy with metallic prosthesis will first consist in describing its efficacy according
to the criteria described above.
Analysis plan :
The statistical analysis will first include a description of the study population with the
number of patients falling under the indication and treated with the Hot AXIOS system at the
recruiting centers (source population), the number of eligible patients who consented to
participate in the study, the number of patients included (study population), the number of
subjects who made each visit and were analyzed, premature exits (deaths, lost to follow-up)
will be reported and described in the form of a flow chart.
What are the participation requirements?
Inclusion Criteria
- 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
Locations
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Status
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
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