MedTrace Logo

Prospective Observational Study for the Evaluation of VEOFIX Varisation Staples

NCT05523219 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 81

Last updated 2024-05-01

Study results available
· View outcomes & findings →

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

Sponsors & Collaborators

  • Societe dEtude, de Recherche et de Fabrication

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-15
Primary Completion
2022-03-02
Completion
2022-06-07

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05523219 on ClinicalTrials.gov