Image Fusion in the OR

Study Overview
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Brief Summary
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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
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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. We 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. For ablations, we further track the needle and overlay its path on the AR view for precise needle placement. This study is designed to test this minimal-risk capability in patients referred for relevant laparoscopic procedures.

Official Title
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Ultrasound Augmentation of Stereoscopic and Conventional Video for Laparoscopic Surgeries

Conditions
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Laparoscopic Cholecystectomy, Liver Ablation

Intervention / Treatment
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* Device: LapAR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Referred for laparoscopic cholecystectomy or liver ablation Clinical indication for the use of laparoscopic ultrasound Patient or an authorized guardian provides written consent Exclusion Criteria: Patients with pacemaker or any other ICD (intra-cardiac device) which may interfere with electromagnetic tracking

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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 map (transform) the live LUS image in the reference frame of the laparoscopic camera, and fuse it with the live laparoscopic video in real time. For thermal ablations that involve a needle, we also track the needle and overlay its path on the AR view.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability | The ease of use of the LapAR system will be evaluated by the surgeon | post surgery, an expected average of 5 minutes | 
| System set-up time |  | before surgery, an expected average of 15 min | 

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