Feasibility and Safety of Augmented Reality (AR) in Liver Tumor Surgery
ConditionLiver Neoplasms
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNavari Surgical AB
About this trial
The purpose of the trial is to evaluate a computer-based Augmented Reality System intended to help surgeons perform keyhole surgery (laparoscopy) for the removal of liver tumors more efficiently and with greater patient safety.
In keyhole surgery, the operation is performed using a small camera that is inserted into the abdominal cavity of the patient through surgical trocars placed through small incisions in the skin. The surgeon then performs the operation by guidance from the view from the camera, which shows the surgical area, i.e. the liver and the inside of the abdomen, on a screen in front of them.
The clinical trial will evaluate a computer-based system that uses a technology known as augmented reality, or AR. In simple terms, this is a technology that superimposes a computer-generated image on a user's view of the real world, thus providing a composite view. In this case, a computer program will integrate an image showing the tumor's appearance and position inside the liver into the live video feed from the camera, which is then displayed on the existing TV screen, connected to the keyhole camera.
Put simply, the AR-projection will appear as an illustrated overlay on the surface of the liver, showing the appearance and position of the tumor throughout the procedure. This may give the surgeon and operating room staff a better understanding of the tumor's location, helping them perform the procedure more safely, accurately and efficiently.
To help the computer-based system with positioning of the illustrated overlay correctly on the liver, a small self-adhesive plastic marker, measuring 11x11 mm, will be placed on the surface of the liver while the operation is being carried out. The marker is inserted through the surgical trocars already placed in the abdominal cavity and will be removed from the body before the operation is completed.
The purpose of the clinical trial is to assess whether this new technology can help achieve greater accuracy, increased patient safety and a more efficient surgical workflow when tumors in the liver are removed using keyhole surgery. A total of 6 participants will be included in the trial.
The clinical trial has been approved by the Swedish Medical Products Agency following an opinion from the Swedish Ethical Review Authority.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Augmented reality guided liver tumor surgery
Procedure/SurgeryThis is a first-in-human, clinical trial, using the augmented reality system developed by Navari Surgical
Augmented reality (AR) guided liver tumor surgery
DeviceThis is the first-in-human, clinical trial, for using the augmented reality system in patients undergoing minimally invasive liver surgery for the removal of liver tumors.
Treatment groups
6 Participants
are divided into 1 treatment groupGroup A: Augmented reality in liver tumor surgeryExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of radical resections and evaluation of resected tumor margins.
The augmented reality system's ability to assist surgeons in achieving radical tumor resections (i.e. the resected tumor has a margin larger than 0 mm). The number of radical resections is recorded, and the system's predicted margin of 10 mm is compared with the resected tumor margin determined by pathological examination.
Time frame
5 weeksSecondary outcomes
1
Time to complete resection of the tumor.
Time for complete resection of the tumor, from the point at which the surgeon starts the resection to the point at which the tumor is removed from the liver parenchyma.
Time frame
Day 02
Time for total procedure using the augmented reality system.
Time for the total procedure using the Navari System, from when the Navari Landmark is placed on the liver surface to when the tumor is removed from the liver parenchyma.
Time frame
Day 03
Time for total surgical procedure
Time for total procedure, from the first incision for applying the trocar to the last incision is closed.
Time frame
Day 0Other outcomes
1
Safety endpoints
Safety endpoint(s): Number and description of Adverse Event (AE), Number of Adverse Device Effect (ADE), Number of Serious Adverse Event (SAE) Serious Adverse Device Effect (SADE) and Device Deficiency (DD).
Time frame
Through study completion, an avarage of 5 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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