CARLO® is the world's first medical, tactile robot that can cut bones contact-free and autonomously with cold laser technology. The innovation is a development of the Basel-based medtech start-up "Advanced Osteotomy Tools - AOT AG". AOT was founded in 2010 by Dr. Alfredo Bruno, Prof. Philippe Cattin and Prof. Hans-Florian Zeilhofer from the High-Tech Research Center at the University Hospital Basel (USB) and Prof. Philipp Jürgens, senior physician at the Oral and Maxillofacial Surgery Unit at the USB. Each of the four founders brought substantial knowledge in the disciplines of laser physics, robotics and bone surgery to the company.
CARLO® enables for the first time to cut human bone using a robot-assisted laser instead of the usual surgical instruments, such as a saw or a drill.
This first-in-man study is designed to confirm the performance and safety of the CARLO® surgical robot for performing preoperatively planned midface osteotomies. The study will test whether CARLO® can be used to perform straight midface osteotomies according to preoperative planning and whether its use is comparable to current osteotomy methods in terms of incisional outcome, safety profile and soft tissue injury/healing.
First-In-Man Performance and Safety Evaluation of the CARLO® (Cold Ablation Robot-guided Laser Osteotome) Device in Midface Osteotomies
Prof. Andreas Müller, University Hospital Basel
4 (Basel, Aarau, Hamburg, Wien)
Duration of the project
Statistics, Regulatory Affairs, Data Management, On Site Management, Monitoring
Clinical testing of a medical device has become complex and regulatory burdensome. However, it is important that we can also conduct clinical research at the USB and actively participate in the transfer of innovative surgical techniques to the hospital. The DKF with its team is a reliable research partner for this.PD Dr. Andreas Müller, Senior Physician at the Oral and Maxillofacial Surgery Unit at USB
Prospective, multicenter, single-arm, unblinded, confirmatory clinical study
Importance of the study
This study serves as the basis for the CE marking of CARLO® and thus for the market launch of the laser-controlled surgical robot in Europe and the USA.
CARLO® non-contact laser technology enables the entire process from preoperative planning to the incision to be completely digitized. Cutting gauges or special instruments are no longer necessary. In addition, the laser technology ensures the safe use of robots in osteotomies, since the cutting instrument, the laser, can be removed immediately at the speed of light and without danger in the case of erratic patient movements. CARLO® only cuts when the patient and the robot are synchronized. Another advantage of the new technology is the ability to execute freely definable cutting patterns, which allows new and gentler surgical techniques. This is expected to accelerate the bone healing process, as preclinical studies indicate.
The laser is universally applicable to the entire body. Similar to a smartphone, the technology enables the upload of applications that support the physician in the complete implementation of the procedure. A first such APP has been developed by AOT for the indication "upper jaw correction". Further indications will follow. After successful study and approval of the device, it is planned to commercialize the device internationally.