Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT03670849
Recruitment Status : Not yet recruiting
First Posted : September 14, 2018
Last Update Posted : July 12, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
IGI Technologies, Inc.
Information provided by (Responsible Party):
Raj Shekhar, Children's Research Institute

Tracking Information
First Submitted Date  ICMJE September 12, 2018
First Posted Date  ICMJE September 14, 2018
Last Update Posted Date July 12, 2019
Estimated Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2018)
  • 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
  • System set-up time [ Time Frame: before surgery, an expected average of 15 min ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03670849 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Image Fusion in the OR
Official Title  ICMJE Clinical Translation of Augmented Reality Visualization for Laparoscopic Surgery
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. This study is designed to test this minimal-risk capability in patients referred for relevant laparoscopic procedures.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Laparoscopic Cholecystectomy
Intervention  ICMJE Device: LapAR
LapAR system will be used for visualization of anatomy prior to surgery starts
Study Arms  ICMJE Experimental: Patients using LapAR system
Intervention: Device: LapAR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 12, 2018)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2020
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Raj Shekhar, PhD 202-476-1201 rshekhar@childrensnational.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03670849
Other Study ID Numbers  ICMJE Pro00003344
2R42CA192504 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Raj Shekhar, Children's Research Institute
Study Sponsor  ICMJE Raj Shekhar
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Cancer Institute (NCI)
  • IGI Technologies, Inc.
Investigators  ICMJE Not Provided
PRS Account Children's Research Institute
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP