Feasibility and Safety of Augmented Reality (AR) in Liver Tumor Surgery
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.
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Mats Ahlenius
- Numéro de téléphone: +46735330301
- E-mail: mats@navarisurgical.com
Sauvegarde des contacts de l'étude
- Nom: Axel Blomé
- Numéro de téléphone: +46736333384
- E-mail: axel@navarisurgical.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Faisabilité de l'appareil
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Augmented reality in liver tumor surgery
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.
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This is a first-in-human, clinical trial, using the augmented reality system developed by Navari Surgical
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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of radical resections and evaluation of resected tumor margins.
Délai: 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.
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5 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time to complete resection of the tumor.
Délai: Day 0
|
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.
|
Day 0
|
|
Time for total procedure using the augmented reality system.
Délai: Day 0
|
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.
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Day 0
|
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Time for total surgical procedure
Délai: Day 0
|
Time for total procedure, from the first incision for applying the trocar to the last incision is closed.
|
Day 0
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Safety endpoints
Délai: Through study completion, an avarage of 5 weeks
|
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).
|
Through study completion, an avarage of 5 weeks
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Svein Olav Bratlie, MD, PhD, Department of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NAV-001
- CIV-25-09-054620 (Autre identifiant: Swedish Medical Products Agency)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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