NCT07630610

Brief 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Jun 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Jun 2026Feb 2027

First Submitted

Initial submission to the registry

May 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

8 months

First QC Date

May 27, 2026

Last Update Submit

June 1, 2026

Conditions

Liver Neoplasms

Keywords

Liver tumor resectionAugmented realityMinimally invasive surgery

Outcome Measures

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.

    5 weeks

Secondary Outcomes (3)

  • Time to complete resection of the tumor.

    Day 0

  • Time for total procedure using the augmented reality system.

    Day 0

  • Time for total surgical procedure

    Day 0

Other Outcomes (1)

  • Safety endpoints

    Through study completion, an avarage of 5 weeks

Study Arms (1)

Augmented reality in liver tumor surgery

EXPERIMENTAL

The Navari System provides surgeons and healthcare professionals with Augmented Reality (AR) guidance in real-time during minimally invasive liver surgery. A patient-specific tumor model is created from Cone Beam Computed Tomography (CBCT) data and presented in AR-format as an integrated part of the video feed from the minimally invasive camera. The AR-overlay communicates the tumor's position inside the liver in real-time during surgery, supporting the surgeon with intraoperative decision-making, increasing surgical precision, and minimizing the risk of incomplete tumor removal.

Procedure: Augmented reality guided liver tumor surgeryDevice: Augmented reality (AR) guided liver tumor surgery

Interventions

Augmented reality guided liver tumor surgeryPROCEDURE

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

Augmented reality in liver tumor surgery
Augmented reality (AR) guided liver tumor surgeryDEVICE

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.

Augmented reality in liver tumor surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Study Officials

  • Svein Olav Bratlie, MD, PhD

    Department of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mats Ahlenius

CONTACT

+46735330301mats@navarisurgical.com

Axel Blomé

CONTACT

+46736333384axel@navarisurgical.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2026

First Posted

June 5, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

June 5, 2026

Record last verified: 2026-06