Malocclusion, Angle Class III Clinical Trial
Official title:
First-In-Man Performance and Safety Evaluation of the CARLO® Device in Midface Osteotomies
The study product is a Cold Ablation Robot-guided Laser Osteotome (CARLO®) robotic surgery device. It is a device that removes hard tissue such as bone by means laser ablation - it is therefore an alternative to Piezo-Electric osteotomes and/or oscillating saws or other mechanical instruments for bone cutting. In this study, the CARLO device is integrated with a computer-assisted pre-operative planning and intra-operative navigation, and will be used for Patients requiring an orthognathic procedure with a mid-face osteotomy, for whom a procedure plan is defined based on preoperative imaging.
The objective of this first-in-man study is to confirm the performance and safety of the
CARLO® robotic surgery device (manufactured by Advanced Osteotomy Tools SA) for the execution
of preoperatively planned midface osteotomies.
The study is designed and powered to confirm, in clinical use across multiple sites, that the
CARLO® device can be used to accurately perform straight-line mid-face osteotomies according
to preoperative plans, and with results and a safety profile that are comparable to current
state-of-the-art osteotomy methods. Multiple risk mitigations are in place to ensure safety,
especially for the initially enrolled patients.
A postoperative follow-up of up to 28 days will be included in this study, in order to assess
initial soft tissue healing and recovery, and to enable the identification of any soft-tissue
injuries that would not have been immediately apparent.
After end of study of each individual patient, safety monitoring will go on for the duration
of the study until the last visit of the last patient.
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