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Prospective Observational Study for the Evaluation of VEOFIX Varisation Staples

Hallux Valgus Clinical Trial

Official title:
Prospective Observational Study for the Evaluation of VEOFIX Varisation Staples

Clinical Trial 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 score's evolution, - To evaluate patient's 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 15/02/2021 and 15/05/2021. 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 14155:2020 "Good Clinical Practice"undirectly applicable; - Regulation (UE) 2016/679 (RGPD) ; - Regulation (UE) 2017/745 (MDR) ; - MEDDEV 2.12.1; - 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05523219
Study type Observational
Source Societe dEtude, de Recherche et de Fabrication
Contact
Status Completed
Phase
Start date February 15, 2021
Completion date June 7, 2022
View Details
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