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

Primary Purpose

Abnormalities, Jaw, Malocclusion, Angle Class III

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Mid-face osteotomy

About this trial

This is an interventional treatment trial for Abnormalities, Jaw

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

[ 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

Exclusion Criteria:

[ 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).
Patient has previously undergone radiotherapy in the region of the intended osteotomy
Patients with impaired wound healing, for example due to Type II diabetes

Sites / Locations

Allgemeines Krankenhaus der Stadt Wien (AKH Wien)
Universitätsklinikum Hamburg-Eppendorf
Kantonsspital Aarau AG
Universitätsspital Basel

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Laser osteotomy

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

Secondary Outcome Measures

Key variables of the osteotomy procedures (durations)

Variables assessed include: Duration of overall osteotomy procedure (first skin incision to skin closure). 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). Duration of CARLO® device cutting for each osteotomy.

Absence of unusual complications that delay initial patient discharge.

Overall well-being of the patient allows a normal discharge from the hospital without unusual delay (within one week).

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

During the visit scheduled at 14 days, soft tissue healing allows the removal of stitches as normally possible.

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

During the visit scheduled at 28 days, absence of any anomaly or concern related to post-operative healing.

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

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.

Accuracy of the final maxilla location, compared to plan, based on postoperative imaging

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.

Full Information

NCT ID

NCT03901209

First Posted

April 1, 2019

Last Updated

September 25, 2020

Sponsor

Advanced Osteotomy Tools (AOT) AG

Collaborators

Clinical Trial Unit, University Hospital Basel, Switzerland

1. Study Identification

Unique Protocol Identification Number

NCT03901209

Brief Title

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

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

July 1, 2019 (Actual)

Primary Completion Date

August 28, 2020 (Actual)

Study Completion Date

August 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Advanced Osteotomy Tools (AOT) AG

Collaborators

Clinical Trial Unit, University Hospital Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Abnormalities, Jaw, Malocclusion, Angle Class III

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Laser osteotomy

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Mid-face osteotomy

Other Intervention Name(s)

Orthognathic Surgery, LeFort I

Intervention Description

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.

Primary Outcome Measure Information:

Title

Technical Success of Device Use

Description

Time Frame

Upon completion of the procedure

Title

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

Description

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.

Time Frame

Intra-operative observation

Title

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

Description

Time Frame

Intra-operative observation

Title

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

Description

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

Time Frame

Intra-operative observation

Secondary Outcome Measure Information:

Title

Key variables of the osteotomy procedures (durations)

Description

Time Frame

Upon completion of the procedure

Title

Absence of unusual complications that delay initial patient discharge.

Description

Overall well-being of the patient allows a normal discharge from the hospital without unusual delay (within one week).

Time Frame

1 week post-procedure

Title

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

Description

During the visit scheduled at 14 days, soft tissue healing allows the removal of stitches as normally possible.

Time Frame

2 weeks post-procedure

Title

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

Description

During the visit scheduled at 28 days, absence of any anomaly or concern related to post-operative healing.

Time Frame

4 weeks post-procedure

Title

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

Description

Time Frame

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

Title

Accuracy of the final maxilla location, compared to plan, based on postoperative imaging

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: [ 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 Exclusion Criteria: [ 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). Patient has previously undergone radiotherapy in the region of the intended osteotomy Patients with impaired wound healing, for example due to Type II diabetes

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andreas Müller

Organizational Affiliation

Universitätsspital Basel

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Marcello Augello

Organizational Affiliation

Kantonsspital Aarau

Official's Role

Principal Investigator

Facility Information:

Facility Name

Allgemeines Krankenhaus der Stadt Wien (AKH Wien)

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Universitätsklinikum Hamburg-Eppendorf

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Kantonsspital Aarau AG

City

Aarau

State/Province

ZIP/Postal Code

5051

Country

Switzerland

Facility Name

Universitätsspital Basel

City

Basel

State/Province

ZIP/Postal Code

4031

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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