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

Summary

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.

Conditions

• Liver Neoplasms

Interventions

PROCEDURE

Augmented reality guided liver tumor surgery

This is a first-in-human, clinical trial, using the augmented reality system developed by Navari Surgical

DEVICE

Augmented reality (AR) guided liver tumor surgery

This 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.

Sponsors & Collaborators

• Navari Surgical AB

  lead INDUSTRY

Principal Investigators

• Svein Olav Bratlie, MD, PhD · Department of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden

Study Design

Allocation

NA

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-01

Primary Completion

2027-02-01

Completion

2027-02-01