First-In-Man Performance and Safety Evaluation of the CARLO® Device in Midface Osteotomies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03901209|
Recruitment Status : Completed
First Posted : April 3, 2019
Last Update Posted : September 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Abnormalities, Jaw Malocclusion, Angle Class III||Device: Mid-face osteotomy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|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)|
|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|
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
- 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.
- Key variables of the osteotomy procedures (durations) [ Time Frame: Upon completion of the procedure ]
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. [ 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).
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03901209
|Allgemeines Krankenhaus der Stadt Wien (AKH Wien)|
|Wien, Austria, 1090|
|Hamburg, Germany, 20246|
|Kantonsspital Aarau AG|
|Aarau, AG, Switzerland, 5051|
|Basel, BS, Switzerland, 4031|
|Principal Investigator:||Andreas Müller||Universitätsspital Basel|
|Principal Investigator:||Marcello Augello||Kantonsspital Aarau|