NCT05523219

Prospective Observational Study for the Evaluation of VEOFIX Varisation Staples

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 81 (actual)
• Sponsor: Societe dEtude, de Recherche et de Fabrication · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hallux Valgus

Timeline

• Start date: 2021-02-15
• Primary completion: 2022-03-02
• Completion: 2022-06-07
• First posted: 2022-08-31
• Last updated: 2024-05-01
• Results posted: 2024-05-01

Locations

1 site across 1 country: France