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Multicentric Observational Study Confirming the Performance and Safety of the Axiom® BL X3 Implants — Prospective_X3  

Edentulous Jaw Clinical Trial

Official title:
Multicentric Observational Study Confirming the Performance and Safety of the Axiom® BL X3 Implants

Clinical Trial Summary

This Post-Market Clinical Follow-Up study aims to document the success and survival of the Axiom® BL X3 Implants up to 3 years after loading.

Clinical Trial Description

The total study duration for each patient should be 3 years after loading. . The investigational devices are CE-(Conformité Européenne, meaning European Conformity) marked product. 14 centers will participate in France Implants used are Axiom® BL X3 with lengths ranging from 6.5 to 18 mm and diameters ranging from 3.4 to 6.4 mm. The study and any amendments will be performed as far as possible according to International Organization for Standardization (ISO) 14155, 21CFR 820 for FDA requirement and conform to the Declaration of Helsinki (last revision Fortaleza 2013) and local legal and regulatory requirements. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05768295
Study type Interventional
Source Anthogyr
Contact Marie Chauvet
Phone +33 (0)4 50 58 02 37
Email marie.chauvet@anthogyr.com
Status Recruiting
Phase N/A
Start date April 5, 2023
Completion date July 2027
View Details
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