The Department of Clinical Research is accompanying a first-in-man study of the innovative robot-assisted surgical system "CARLO®", a development from the Basel start-up "AOT".

AOT launched the first-in-man CARLO® study in Basel in collaboration with the research group led by PD Dr. Andreas Müller, Senior Physician for oral and maxillofacial surgery at the USB, and the Department of Clinical Research (DKF). Meanwhile, 28 patients were treated successfully with transoral midface osteotomies using contactless robot-assisted surgery in Basel, Vienna and Hamburg. The study is close to its end and is intended to demonstrate the safety and performance of the CARLO® device. It will serve as the basis for a CE certification and, consequently, for its market launch in Europe and the USA.

Silke Purschke, Study Nurse at the DKF, accompanied Andreas Müller's research team into the operating theatre. She documented that all operations during the procedure are carried out accurately and strictrly according to the protocol. She also coordinated and documented all follow-up visits with the Basel patients. It is crucial to know how the healing process progresses for the individual study participants after the use of CARLO®. For Andreas Müller and his team, the first-in-man study is also an instructive and interesting experience.

The CARLO® contactless laser technology makes it possible to completely digitise the entire process from preoperative planning to incision. Cutting jigs or special instruments are no longer necessary. In addition, laser technology ensures the safe use of robotics for osteotomies, since the cutting instrument, the laser, can be removed immediately and safely at the speed of light in case of erratic patient movements. CARLO® only cuts when the patient and the robot are synchronised. Another advantage of the new technology is the ability to execute freely defined cutting patterns, which allows for new and gentler surgical techniques. This should accelerate the bone healing process, as seen in promising results from preclinical studies.

The laser can be used universally on the entire body. Similar to a smartphone, the technology enables the upload of applications that support the physician in the complete implementation of the intervention. One initial app has been developed by AOT for the indication "maxillary correction". Further indications will follow. Upon successful study completion and approval, the device would be marketed internationally.

Department of Clinical Research, June 2020