Feasibility and Safety of Augmented Reality (AR) in Liver Tumor Surgery

Cancer is the second-leading global health threat, accounting for approximately 18% of fatalities worldwide and leading to 10 million deaths each year. In addition, in 2020, 19.3 million people were diagnosed with some type of cancer worldwide and the cumulative risk of getting cancer was as high as 39.6%.

About 60% of cancer patients will require surgical intervention to remove the tumor at some point in their treatment pathway.

In the past few decades, laparoscopic minimally invasive surgery (LMIS) has gained traction across various medical specialties, including oncology. This technique has consistently demonstrated improved postoperative outcomes compared with open surgery.

The Navari System is a visualization tool for minimally invasive liver surgery, which will give the operator a visualization of the tumor's position under the tissue surface in real time during the surgical procedure. The system utilizes the video feed from the minimally invasive camera to provide the operator with an augmented reality (AR) overlay of the tumor. The AR-overlay is created from patient-specific x-ray data, provided in real-time during the surgical procedure, and is shown as an integrated part of the video feed from the minimally invasive camera. To provide the operator with depth perception, the system will provide two views simultaneously, one from the camera angle and one additional view from another angle selected through the Navari user interface.

The rationale for this clinical investigation is to evaluate safety and performance of the Navari System, in its initial clinical application, minimally invasive liver tumor surgical resection.

Inclusion criteria

• Subject scheduled for liver tumor resection of one or more tumors. One tumor per surgery is always chosen as the study tumor and will be removed first.
• The tumor must be susceptible to uncomplicated wedge resection within one to two segments.
• The tumor has been diagnosed as malignant or is suspected to be malignant based on imaging or clinical assessment.
• The tumor's size should not exceed 50 mm in any orientation.
• Subject 18 years or older.
• Subject is able to read and understand the Patient information which is written in Swedish.
• Subject has given consent to study participation.

Exclusion criteria

• Unresectable tumors.
• Not uncomplicated resection (e.g. central resection, re-resection, or large resection, defined as resection of more than two segments).
• Subject is not suitable for MIS, as judged by the principal investigator.
• Subject with reduced kidney function.
• Subject with known hypersensitivity to contrast agents.
• Subject considered unable to comply with hospital's instructions, at the discretion of the principal investigator.
• Subject is not suitable for inclusion in the opinion of the investigator.
• Pregnant women.