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Image Fusion in the OR

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03670849
Recruitment Status : Not yet recruiting
First Posted : September 14, 2018
Last Update Posted : July 12, 2019
National Institutes of Health (NIH)
National Cancer Institute (NCI)
IGI Technologies, Inc.
Information provided by (Responsible Party):
Raj Shekhar, Children's Research Institute

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.

Condition or disease Intervention/treatment Phase
Laparoscopic Cholecystectomy Device: LapAR Not Applicable

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. This study is designed to test this minimal-risk capability in patients referred for relevant laparoscopic procedures.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Clinical Translation of Augmented Reality Visualization for Laparoscopic Surgery
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Arm Intervention/treatment
Experimental: Patients using LapAR system Device: LapAR
LapAR system will be used for visualization of anatomy prior to surgery starts

Primary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Referred for laparoscopic surgery of the hepatobiliary system
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03670849

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Contact: Raj Shekhar, PhD 202-476-1201

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United States, District of Columbia
Children's National Health System Not yet recruiting
Washington, District of Columbia, United States, 20010
Contact: Raj Shekhar, PhD    202-476-1201   
Sponsors and Collaborators
Raj Shekhar
National Institutes of Health (NIH)
National Cancer Institute (NCI)
IGI Technologies, Inc.

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Responsible Party: Raj Shekhar, Principal Investigator, Children's Research Institute Identifier: NCT03670849     History of Changes
Other Study ID Numbers: Pro00003344
2R42CA192504 ( U.S. NIH Grant/Contract )
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Raj Shekhar, Children's Research Institute:
Laparoscopic Ultrasound