Liver NeoplasmsNCT07630610
Feasibility and Safety of Augmented Reality (AR) in Liver Tumor Surgery
A study testing Augmented reality guided liver tumor surgery and Augmented reality (AR) guided liver tumor surgery in people with Liver Neoplasms, run by Navari Surgical AB.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Neoplasms
- What is being tested?
- Augmented reality guided liver tumor surgery and Augmented reality (AR) guided liver tumor surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Feasibility and Safety of Augmented Reality (AR) Assistance System in Liver Tumor Surgery - a Single-center, Exploratory, Pilot Study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Liver Neoplasms
- Being tested
- Augmented reality guided liver tumor surgery, Augmented reality (AR) guided liver tumor surgery
- Keywords
- Liver tumor resection, Augmented reality, Minimally invasive surgery
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented reality guided liver tumor surgeryProcedure or surgery
This is a first-in-human, clinical trial, using the augmented reality system developed by Navari Surgical
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Augmented reality guided liver tumor surgery; Device: Augmented reality (AR) guided liver tumor surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks
Secondary outcomes (3)
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.
Measured: Day 0
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.
Measured: Day 0
Time for total surgical procedure
Time for total procedure, from the first incision for applying the trocar to the last incision is closed.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Navari Surgical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Svein Olav Bratlie, MD, PhD, Principal investigator, Department of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630610
- Sponsor's protocol ID
- NAV-001
- Other IDs
- CIV-25-09-054620
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Augmented Reality (AR) Assistance System in Liver Tumor Surgery - a Single-center, Exploratory, Pilot Study
- ClinicalTrials.gov ID
- NCT07630610
- Acronym / sponsor ID
- NAV-001
- Conditions
- Liver Neoplasms
- Keywords
- Liver tumor resection, Augmented reality, Minimally invasive surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Navari Surgical ABIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Augmented reality in liver tumor surgery | Experimental | Procedure: Augmented reality guided liver tumor surgery, Device: Augmented reality (AR) guided liver tumor surgeryThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented reality guided liver tumor surgeryThis is a first-in-human, clinical trial, using the augmented reality system developed by Navari Surgical | Procedure or surgery | Augmented reality in liver tumor surgery |
| Augmented reality (AR) guided liver tumor surgeryThis 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. | Device | Augmented reality in liver tumor surgery |
Primary outcome
Number of radical resections and evaluation of resected tumor margins.
Time frame: 5 weeks
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.
3 secondary outcomes
Time to complete resection of the tumor.
Time frame: Day 0
Time for total procedure using the augmented reality system.
Time frame: Day 0
Time for total surgical procedure
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Svein Olav Bratlie, MD, PhD principal investigator
Department of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden
Questions about this trial
What is this clinical trial studying?
A study testing Augmented reality guided liver tumor surgery and Augmented reality (AR) guided liver tumor surgery in people with Liver Neoplasms, run by Navari Surgical AB.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mats Ahlenius (+46735330301, mats@navarisurgical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of radical resections and evaluation of resected tumor margins. (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.