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

NCT03901209 | Completed

• 1 other identifier: AOT2019-01
• Study Type: interventional
• Target: 31
• Locations: 3 countries
• Sites: 4

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.

Conditions

Abnormalities, Jaw; Malocclusion, Angle Class III

Outcome Measures

Primary Outcomes (4)

• Technical Success of Device Use

  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.

  Upon completion of the procedure

• RMS error during registration of in-situ patient with pre-operative model

  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.

  Intra-operative observation

• Position of the performed osteotomies is within 2 mm of the preoperatively planned location.

  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.

  Intra-operative observation

• Successful completion of the maxillary downfracture and procedure without unusual difficulties.

  The maxillary mobilization (pterygo-maxillary disjunction, pull-down fracture) can be completed as usual. No difficulty is encountered that is unusual for the procedure.

  Intra-operative observation

Secondary Outcomes (6)

• Key variables of the osteotomy procedures (durations)

  Upon completion of the procedure

• Absence of unusual complications that delay initial patient discharge.

  1 week post-procedure

• Absence of unusual soft tissue healing difficulties (14 days status).

  2 weeks post-procedure

• Absence of healing anomalies during final visit (28 days status)

  4 weeks post-procedure

• Accuracy of the execution of the planned osteotomy based on postoperative imaging

  Assessed ~2 weeks postoperatively based on postoperative imaging (CBCT)

Study Arms (1)

Laser osteotomy

EXPERIMENTAL

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

Interventions

Mid-face osteotomy DEVICE

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.

Also known as: Orthognathic Surgery, LeFort I

Laser osteotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \[ Indication for performing a mid-face osteotomy using a transoral approach, and suitability for use of CARLO® system: \]
• 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.
• \[ General requirements related to enrollment in a clinical study \]
• Patient is willing and able to attend all scheduled visits and comply with all study procedures
• Aged ≥18
• Ability to understand and give study-specific informed consent
• Written informed consent obtained from patient \[ General precondition for orthognathic surgery \]
• Proven completion of the facial growth

You may not qualify if:

• \[ General contraindications related to enrollment in a clinical study \]
• Female patients who are pregnant or breast feeding or are planning to become pregnant during the study
• Other patients who are vulnerable persons, such as adults lacking the capacity in the consent procedure, patients in emergency situations.
• Known or suspected non-compliance, drug or uncontrolled alcohol abuse.
• 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
• The patient is participating in, or intends to participate in another investigational drug or device clinical trial within 12 months after enrollment
• Enrolment of the Investigator, his/her family members, employees and other dependent persons \[ General contraindications for orthognathic surgery \]
• Missing indication for orthognathic surgery
• Patients with bleeding diathesis or coagulopathy
• Patients with increased perioperative airway risk factors due to anatomical structures which limits usage of endotracheal intubation
• Patients with intolerance or hypersensitivity to local anesthetics
• Patients with consumptive/malignant primary disease (e.g. renal failure, hepatic dysfunction, severe heart failure, etc.) and a life expectancy of \< 6 months
• Patients that have an odontogenic osteomyelitis
• Patients that have a diagnosed bone metabolism disorder e.g. Osteoporosis, Osteomalacia, Paget's disease, renal osteodystrophy, parathyroid disorders
• Patients who have received or are receiving antiresorptive therapy (bisphosphonates).

Sponsors & Collaborators

• Advanced Osteotomy Tools (AOT) AG: lead
• Clinical Trial Unit, University Hospital Basel, Switzerland: collaborator

Study Sites (4)

Allgemeines Krankenhaus der Stadt Wien (AKH Wien)

Vienna, 1090, Austria

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Kantonsspital Aarau AG

Aarau, Canton of Aargau, 5051, Switzerland

Location

Universitätsspital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

Jaw Abnormalities; Malocclusion, Angle Class III

Interventions

Orthognathic Surgery

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Malocclusion; Tooth Diseases

Intervention Hierarchy (Ancestors)

Surgery, Oral; Dentistry

Study Officials

• Andreas Müller

  Universitätsspital Basel

  PRINCIPAL INVESTIGATOR

• Marcello Augello

  Kantonsspital Aarau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 3, 2019
• Study Start: July 1, 2019
• Primary Completion: August 28, 2020
• Study Completion: August 28, 2020
• Last Updated: September 28, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); CH (2); DE (1)