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.

Eligibility Criteria:
Inclusion Criteria:

\[ Indication for performing a mid-face osteotomy using a transoral approach, and suitability for use of CARLO® system: \]

1. Surgical relocation of the maxilla is indicated, using a mid-face osteotomy via a transoral approach that can be performed using bilateral straight-cut lines (LeFort I). Patients for whom a concomitant re-positioning of the mandibula or other corrections are indicated may be included in the study, as long as these corrections do not affect the repositioning of the maxilla that is being assessed; these additional osteotomies will not be performed using the CARLO® system.

   \[ General requirements related to enrollment in a clinical study \]
2. Patient is willing and able to attend all scheduled visits and comply with all study procedures
3. Aged ≥18
4. Ability to understand and give study-specific informed consent
5. Written informed consent obtained from patient \[ General precondition for orthognathic surgery \]
6. Proven completion of the facial growth

Exclusion Criteria:

\[ General contraindications related to enrollment in a clinical study \]

1. Female patients who are pregnant or breast feeding or are planning to become pregnant during the study
2. Other patients who are vulnerable persons, such as adults lacking the capacity in the consent procedure, patients in emergency situations.
3. Known or suspected non-compliance, drug or uncontrolled alcohol abuse.
4. Presence of any condition or abnormality that in the opinion of the Investigator of the Investigator would compromise the safety of the patient or quality of the data
5. The patient is participating in, or intends to participate in another investigational drug or device clinical trial within 12 months after enrollment
6. Enrolment of the Investigator, his/her family members, employees and other dependent persons \[ General contraindications for orthognathic surgery \]
7. Missing indication for orthognathic surgery
8. Patients with bleeding diathesis or coagulopathy
9. Patients with increased perioperative airway risk factors due to anatomical structures which limits usage of endotracheal intubation
10. Patients with intolerance or hypersensitivity to local anesthetics
11. Patients with consumptive/malignant primary disease (e.g. renal failure, hepatic dysfunction, severe heart failure, etc.) and a life expectancy of \< 6 months
12. Patients that have an odontogenic osteomyelitis
13. Patients that have a diagnosed bone metabolism disorder e.g. Osteoporosis, Osteomalacia, Paget's disease, renal osteodystrophy, parathyroid disorders
14. Patients who have received or are receiving antiresorptive therapy (bisphosphonates).
15. Patient has previously undergone radiotherapy in the region of the intended osteotomy
16. Patients with impaired wound healing, for example due to Type II diabetes