First-In-Man Performance and Safety Evaluation of the CARLO® Device in Midface Osteotomies

• ClinicalTrials.gov Identifier: NCT03901209
• Recruitment Status: Completed
• First Posted: April 3, 2019
• Last Update Posted: September 28, 2020
• Sponsor: Advanced Osteotomy Tools (AOT) AG
• Collaborator: Clinical Trial Unit, University Hospital Basel, Switzerland
• Information provided by (Responsible Party): Advanced Osteotomy Tools (AOT) AG

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Abnormalities, Jaw; Malocclusion, Angle Class III	Device: Mid-face osteotomy	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 31 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• 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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: First-In-Man Performance and Safety Evaluation of the CARLO® Device in Midface Osteotomies
• Actual Study Start Date: July 1, 2019
• Actual Primary Completion Date: August 28, 2020
• Actual Study Completion Date: August 28, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Laser osteotomy; The planned mid-face osteotomy (e.g. LeFort I) is performed using the CARLO osteotomy device, where a patient-specific intervention plan based on preoperative imaging is loaded on the system to allow the device to show and suggest a location for the osteotomy.	Device: Mid-face osteotomy; The mid-face osteotomy - typically according to LeFort I - is performed using a pulsed erbium-doped yttrium aluminium garnet (Er:YAG) laser driven by the CARLO robot arm.; Other Name: Orthognathic Surgery, LeFort I

Outcome Measures

Primary Outcome Measures :

1. Technical Success of Device Use [ Time Frame: Upon completion of the procedure ]
   Successful use of the device through all required steps: initial set-up and self-test, selection of each osteotomy path, previsualization of the path, completion of the osteotomies, and system shut down.
2. RMS error during registration of in-situ patient with pre-operative model [ Time Frame: Intra-operative observation ]
   Point-pair matching performed to match preoperative imaging with the in-situ patient could be completed with a Root Mean Square error that does not exceed 1.5 mm.
3. Position of the performed osteotomies is within 2 mm of the preoperatively planned location. [ Time Frame: Intra-operative observation ]
   The postion of the performed osteotomies is measured intraoperatively, relative to (orthogonally located) landmarks selected on the preoperative 3D model. The oucome is successful if this distance does not exceed 2 mm.
4. Successful completion of the maxillary downfracture and procedure without unusual difficulties. [ Time Frame: Intra-operative observation ]
   The maxillary mobilization (pterygo-maxillary disjunction, pull-down fracture) can be completed as usual. No difficulty is encountered that is unusual for the procedure.

Secondary Outcome Measures :

1. Key variables of the osteotomy procedures (durations) [ Time Frame: Upon completion of the procedure ]

   Variables assessed include:

   1. Duration of overall osteotomy procedure (first skin incision to skin closure).
   2. Duration of patient registration with the CARLO® device (from on-screen selection of first point to be matched to display of an accepted Root Mean Square Error value).
   3. Duration of CARLO® device cutting for each osteotomy.
2. Absence of unusual complications that delay initial patient discharge. [ Time Frame: 1 week post-procedure ]
   Overall well-being of the patient allows a normal discharge from the hospital without unusual delay (within one week).
3. Absence of unusual soft tissue healing difficulties (14 days status). [ Time Frame: 2 weeks post-procedure ]
   During the visit scheduled at 14 days, soft tissue healing allows the removal of stitches as normally possible.
4. Absence of healing anomalies during final visit (28 days status) [ Time Frame: 4 weeks post-procedure ]
   During the visit scheduled at 28 days, absence of any anomaly or concern related to post-operative healing.
5. Accuracy of the execution of the planned osteotomy based on postoperative imaging [ Time Frame: Assessed ~2 weeks postoperatively based on postoperative imaging (CBCT) ]
   Accuracy of the performed cut measured on postoperative CT (distance of the cut start and end relative to the incisor point and to the ipsilateral mesio-buccal cuspid, respectively). Target is to perform cut within 2 mm of the planned position.
6. Accuracy of the final maxilla location, compared to plan, based on postoperative imaging [ Time Frame: Assessed ~2 weeks postoperatively based on postoperative imaging (CBCT) ]
   Accuracy of the maxilla relocation, comparing on CT imaging the position of five defined landmarks (e.g. incisor point, tips of the upper canines, tips of the mesio-buccal cuspid) between the plan and the final result.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Austria

Allgemeines Krankenhaus der Stadt Wien (AKH Wien)

Wien, Austria, 1090

Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany, 20246

Switzerland

Kantonsspital Aarau AG

Aarau, AG, Switzerland, 5051

Universitätsspital Basel

Basel, BS, Switzerland, 4031

Sponsors and Collaborators

Advanced Osteotomy Tools (AOT) AG

Clinical Trial Unit, University Hospital Basel, Switzerland

Investigators

• Principal Investigator: Andreas Müller; Universitätsspital Basel
• Principal Investigator: Marcello Augello; Kantonsspital Aarau

More Information

• Responsible Party: Advanced Osteotomy Tools (AOT) AG
• ClinicalTrials.gov Identifier: NCT03901209
• Other Study ID Numbers: AOT2019-01
• First Posted: April 3, 2019
• Last Update Posted: September 28, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Prognathism; Jaw Abnormalities; Malocclusion; Malocclusion, Angle Class III; Congenital Abnormalities; Tooth Diseases; Stomatognathic Diseases; Jaw Diseases; Musculoskeletal Diseases; Mandibular Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic System Abnormalities