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OpenTrials
Completed

NCT Number: NCT03670849

Image Fusion in the OR

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.

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Key information

Conditions

Laparoscopic Cholecystectomy Liver Ablation

Age range

1 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LapAR

Device

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.

Primary outcomes

  1. 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

  2. System set-up time

    Time frame: before surgery, an expected average of 15 min

Sponsors and collaborators

Lead sponsor

Raj Shekhar

Other

Collaborators

  • IGI Technologies, Inc.
  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

Ultrasound Augmentation of Stereoscopic and Conventional Video for Laparoscopic Surgeries

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 14, 2018
Registry last updated
Mar 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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