Abnormalities, JawNCT03901209
First-In-Man Performance and Safety Evaluation of the CARLO® Device in Midface Osteotomies
A study testing Mid-face osteotomy in people with Abnormalities, Jaw and Malocclusion, Angle Class III, run by Advanced Osteotomy Tools (AOT) AG at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abnormalities, Jaw, Malocclusion, Angle Class III
- What is being tested?
- Mid-face osteotomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 1 Jul 2019to 28 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- [ 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
Who cannot join
- [ 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
Show all 17Show fewer
- 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
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Switzerland2 sites
Kantonsspital Aarau AG
Aarau, Canton of Aargau, 5051
Universitätsspital Basel
Basel, Canton of Basel-City, 4031
About this study
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.
Read the 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.
- Conditions
- Abnormalities, Jaw, Malocclusion, Angle Class III
- Being tested
- Mid-face osteotomy
- Medical subject headings
- Jaw Abnormalities, Malocclusion, Angle Class III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mid-face osteotomyDevice
Also called Orthognathic Surgery, LeFort I
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Mid-face osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Intra-operative observation
Secondary outcomes (6)
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.
Measured: Upon completion of the procedure
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).
Measured: 1 week post-procedure
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.
Measured: 2 weeks post-procedure
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.
Measured: 4 weeks post-procedure
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.
Measured: Assessed ~2 weeks postoperatively based on postoperative imaging (CBCT)
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.
Measured: Assessed ~2 weeks postoperatively based on postoperative imaging (CBCT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start1 Jul 2019
- Primary completion28 Aug 2020
- Study completion28 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormalities, JawStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Osteotomy Tools (AOT) AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinical Trial Unit, University Hospital Basel, Switzerland
- Responsible party
- Sponsor
- Investigators
- Andreas Müller, Principal investigator, Universitätsspital BaselMarcello Augello, Principal investigator, Kantonsspital Aarau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901209
- Sponsor's protocol ID
- AOT2019-01
- Status last verified
- Sep 2020
- First submitted
- 1 Apr 2019
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-In-Man Performance and Safety Evaluation of the CARLO® Device in Midface Osteotomies
- ClinicalTrials.gov ID
- NCT03901209
- Acronym / sponsor ID
- AOT2019-01
- Conditions
- Abnormalities, Jaw, Malocclusion, Angle Class III
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Advanced Osteotomy Tools (AOT) AGIndustry (pharma, biotech, devices)
- Collaborators
- Clinical Trial Unit, University Hospital Basel, Switzerland
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 28 Aug 2020 (actual)
- Study completion
- 28 Aug 2020 (actual)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Laser osteotomy | Experimental | Device: Mid-face osteotomyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- [ 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
Key exclusion criteria (17 listed)
- [ 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mid-face osteotomyAlso: Orthognathic Surgery, LeFort IThe 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. | Device | Laser osteotomy |
Primary outcome
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.
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.
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.
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.
6 secondary outcomes
Key variables of the osteotomy procedures (durations)
Time frame: Upon completion of the procedure
Absence of unusual complications that delay initial patient discharge.
Time frame: 1 week post-procedure
Absence of unusual soft tissue healing difficulties (14 days status).
Time frame: 2 weeks post-procedure
Absence of healing anomalies during final visit (28 days status)
Time frame: 4 weeks post-procedure
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 final maxilla location, compared to plan, based on postoperative imaging
Time frame: Assessed ~2 weeks postoperatively based on postoperative imaging (CBCT)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Müller principal investigator
Universitätsspital Basel
Marcello Augello principal investigator
Kantonsspital Aarau
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mid-face osteotomy in people with Abnormalities, Jaw and Malocclusion, Angle Class III, run by Advanced Osteotomy Tools (AOT) AG at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland, Austria, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success of Device Use (time frame: Upon completion of the procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2020.