Clinical Translation of Augmented Reality Visualization for Laparoscopic Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Laparoscopic Hepatectomy
- Sponsor
- IGI Technologies, Inc.
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Surgeon interview regarding usability
- Last Updated
- 7 years ago
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.
Investigators
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
Outcomes
Primary Outcomes
Surgeon interview regarding usability
Time Frame: post surgery, an expected average of 5 minutes
The ease of use of the LapAR system will be evaluated by the surgeon
Procedure time
Time Frame: during surgery
Time of using the LapAR system for laparoscopic hepatectomy and laparoscopic thermal ablation
Measurement of margin
Time Frame: post surgery
Obtain from Pathology department or follow-up imaging
Secondary Outcomes
- System set-up time(before surgery, an expected average of 15 min)