NCT04782414: REALAXIOS

Hot AXIOS® Prosthesis in Real Life Conditions -

Completed Last updated 17 May 2024

What this trial tests

trial testing Hot AXIOS® prosthesis in Pancreatitis,Acute Necrotizing in 176 participants. Completed in 9 November 2023.

Timeline

18 April 2021

Primary endpoint
9 November 2023

9 November 2023

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Nice
Status	Completed
Study type	OBSERVATIONAL
Enrollment	176
Start date	18 April 2021
Primary completion	9 November 2023
Estimated completion	9 November 2023
Sites	17 locations across France

Drugs / interventions tested

• Hot AXIOS® prosthesis

Conditions studied

• Pancreatitis,Acute Necrotizing — all drugs for Pancreatitis,Acute Necrotizing →

Sponsor

Centre Hospitalier Universitaire de Nice

Who can join

18 and older, any sex, with Pancreatitis,Acute Necrotizing. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.