Ignite Creation Date:
2024-05-06 @ 6:03 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05523219
Status:
COMPLETED
Last Update Posted:
2024-05-01
First Post:
2022-08-29
Brief Title:
Prospective Observational Study for the Evaluation of VEOFIX Varisation Staples
Sponsor:
Societe dEtude de Recherche et de Fabrication
Organization:
Societe dEtude de Recherche et de Fabrication
Study Overview
Official Title:
Prospective Observational Study for the Evaluation of VEOFIX Varisation Staples
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
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:
None
Brief Summary:
This clinical investigation was led as a post-market clinical follow-up study post-market device development stage Therefore its objectives were as follows
To assess functional clinical scores evolution
To evaluate patients satisfaction
To confirm safety of varisation staples The target population for this study was any adult patient implanted with VEOFIX varisation staples in their intended uses between 15022021 and 15052021
Patients were implanted and followed as per standard of care led in the investigational site
The following regulation and guidelines were followed for this investigation
Standard ISO 141552020 Good Clinical Practiceundirectly applicable
Regulation UE 2016679 RGPD
Regulation UE 2017745 MDR
MEDDEV 2121
Local regulation loi jardé loi informatique et libertés As per its design the investigation is considered as involving human beings and therefore require submission to an ethic committee or declaration to a Competent Authority ANSM and CPP This study was registered on CPP CPP Ile de France VII
To assess functional clinical scores evolution
To evaluate patients satisfaction
To confirm safety of varisation staples The target population for this study was any adult patient implanted with VEOFIX varisation staples in their intended uses between 15022021 and 15052021
Patients were implanted and followed as per standard of care led in the investigational site
The following regulation and guidelines were followed for this investigation
Standard ISO 141552020 Good Clinical Practiceundirectly applicable
Regulation UE 2016679 RGPD
Regulation UE 2017745 MDR
MEDDEV 2121
Local regulation loi jardé loi informatique et libertés As per its design the investigation is considered as involving human beings and therefore require submission to an ethic committee or declaration to a Competent Authority ANSM and CPP This study was registered on CPP CPP Ile de France VII
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