Image Fusion in the OR

Ultrasound Augmentation of Stereoscopic and Conventional Video for Laparoscopic Surgeries

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03670849

Enrollment

Registered

2018-09-14

Start date

2020-09-29

Completion date

2022-10-28

Last updated

2023-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Cholecystectomy, Liver Ablation

Keywords

Laparoscopic Ultrasound

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. 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.

Interventions

DEVICELapAR

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Referred for laparoscopic cholecystectomy or liver ablation 2. Clinical indication for the use of laparoscopic ultrasound 3. 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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026