NCT05768295

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Anthogyr · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Surgical Operation
• Edentulous Jaw
• Edentulous Mouth
• Implant

Interventions

Type	Name	Description
DEVICE	Axiom BL X3	collecting data on the use of Axiom BL X3 and patient satisfaction

Timeline

• Start date: 2023-04-05
• Primary completion: 2025-08-20
• Completion: 2027-07-01
• First posted: 2023-03-14
• Last updated: 2025-03-19

Locations

13 sites across 1 country: France