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Clinical Trial Summary

International, prospective, single arm, multicenter and observational Post-Market Clinical Follow-up (PMCF). The overall objective of this study is to collect preoperative, intraoperative and postoperative (at 9 weeks, 6 months, 1 year and 2 years) data on the clinical complications and functional outcomes of the study devices to demonstrate safety and performance in a real-world setting. The primary objective is to demonstrate that the use of the study devices is safe. The secondary objective is to demonstrate that the use of the study devices decreases the pain, and improves the quality of life and the daily activities of the subjects.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05170815
Study type Observational
Source Clariance
Contact Florian Laboulfie
Phone +33 7 81 20 03 13
Email f.laboulfie@clariance-spine.com
Status Recruiting
Phase
Start date January 17, 2022
Completion date December 2025

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