Clinical trial NCT03901209: First-In-Man Performance and Safety Evaluation of the CARLO® Device in Midface Osteotomies
Official title: First-In-Man Performance and Safety Evaluation of the CARLO® Device in Midface Osteotomies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abnormalities, Jaw
Malocclusion, Angle Class III
Lead sponsor: Advanced Osteotomy Tools (AOT) AG
Sponsor class: INDUSTRY
Collaborators: name: Clinical Trial Unit, University Hospital Basel, Switzerland
First posted: 2019-04-03
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study design is a prospective, bi-national, multi-center (3 centers), open-label single arm, confirmatory clinical study - with an initial explorative sequential phase.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Primary outcomes:
measure: Technical Success of Device Use
timeFrame: Upon completion of the procedure
measure: RMS error during registration of in-situ patient with pre-operative model
timeFrame: Intra-operative observation
measure: Position of the performed osteotomies is within 2 mm of the preoperatively planned location.
timeFrame: Intra-operative observation
measure: Successful completion of the maxillary downfracture and procedure without unusual difficulties.
timeFrame: Intra-operative observation
Secondary outcomes:
measure: Key variables of the osteotomy procedures (durations)
timeFrame: Upon completion of the procedure
measure: Absence of unusual complications that delay initial patient discharge.
timeFrame: 1 week post-procedure
measure: Absence of unusual soft tissue healing difficulties (14 days status).
timeFrame: 2 weeks post-procedure
measure: Absence of healing anomalies during final visit (28 days status)
timeFrame: 4 weeks post-procedure
measure: Accuracy of the execution of the planned osteotomy based on postoperative imaging
timeFrame: Assessed ~2 weeks postoperatively based on postoperative imaging (CBCT)
measure: Accuracy of the final maxilla location, compared to plan, based on postoperative imaging
timeFrame: Assessed ~2 weeks postoperatively based on postoperative imaging (CBCT)
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Allgemeines Krankenhaus der Stadt Wien (AKH Wien)
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau AG
state: AG
city: Basel
country: Switzerland
facility: Universitätsspital Basel
state: BS
Study officials:
affiliation: Universitätsspital Basel
name: Andreas Müller
role: PRINCIPAL_INVESTIGATOR
affiliation: Kantonsspital Aarau
name: Marcello Augello
role: PRINCIPAL_INVESTIGATOR
References: