Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04782414
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2021-03-01
Brief Title:
Hot AXIOS Prosthesis in Real Life Conditions -
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Centre Hospitalier Universitaire de Nice
Study Overview
Official Title:
Observational Study of Patients Treated With Hot AXIOS Prosthesis in Real Life Conditions -
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
Recruiting
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REALAXIOS
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 andor 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-interventionalobservational 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 eg 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 centres 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
Operators are trained in the use of the equipment practice on ex-vivo model andor 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-interventionalobservational 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 eg 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 centres 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None