Assessment of Augmented Reality in Minimally Invasive Surgery

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to test the technical feasibility of LapAR visualization system for guiding laparoscopic surgeries and to gather clinical feedback on the use of this tool.

Detailed Description
-----------------
Surgeons use real-time video generated by a laparoscope to visualize the operative field when performing laparoscopic procedures. An inability to see beneath organ surfaces is a limitation of the current visualization technology. Surgeons additionally use laparoscopic ultrasound to see beneath organ surfaces, but also need to mentally correlate the ultrasound image with the video of the operative field. This process is difficult, subjective, and variable with expertise, and discourages the use of ultrasound. The investigators have developed a method to combine live laparoscopic video and laparoscopic ultrasound images to present fused multimodality images on a single display, eliminating the need for mental image correlation. Specifically, the image fusion method, called laparoscopic augmented reality (LapAR), augments the laparoscopic video with ultrasound data when required by surgeons. This study is designed to test this minimal-risk capability in patients referred for relevant laparoscopic procedures.

Official Title
-----------------
Clinical Translation of Augmented Reality Visualization for Laparoscopic Surgery

Conditions
-----------------
Laparoscopic Hepatectomy, Laparoscopic Liver Thermal Ablation

Intervention / Treatment
-----------------
* Device: LapAR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is referred for either laparoscopic partial hepatectomy for tumor removal or laparoscopic ablation of liver cancer; Patient must be at least 18 years old; Patient provides written consent; Patient is considered a suitable candidate based on tumor location for using the AR system. Exclusion Criteria: Patients with pacemaker or any other ICD(intra-cardiac device) which may interfere with electromagnetic tracking

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients using LapAR system<br> | Device: LapAR<br>* LapAR system will be used for guidance during laparoscopic hepatectomy and laparoscopic liver thermal ablation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgeon interview regarding usability | The ease of use of the LapAR system will be evaluated by the surgeon | post surgery, an expected average of 5 minutes | 
| Procedure time | Time of using the LapAR system for laparoscopic hepatectomy and laparoscopic thermal ablation | during surgery | 
| Measurement of margin | Obtain from Pathology department or follow-up imaging | post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System set-up time |  | before surgery, an expected average of 15 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laparoscopic Ultrasound