NCT03670849

Image Fusion in the OR

Ultrasound Augmentation of Stereoscopic and Conventional Video for Laparoscopic Surgeries

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Raj Shekhar · Academic / Other
• Sex: All
• Age: 1 Year – 80 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Laparoscopic Cholecystectomy
• Liver Ablation

Interventions

Type	Name	Description
DEVICE	LapAR	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.

Timeline

• Start date: 2020-09-29
• Primary completion: 2022-09-28
• Completion: 2022-10-28
• First posted: 2018-09-14
• Last updated: 2023-03-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study