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Clinical Trials/NCT03670849
NCT03670849
Completed
Not Applicable

Ultrasound Augmentation of Stereoscopic and Conventional Video for Laparoscopic Surgeries

Raj Shekhar1 site in 1 country11 target enrollmentSeptember 29, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Laparoscopic Cholecystectomy
Sponsor
Raj Shekhar
Enrollment
11
Locations
1
Primary Endpoint
System set-up time
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 29, 2020
End Date
October 28, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Raj Shekhar
Responsible Party
Sponsor Investigator
Principal Investigator

Raj Shekhar

Principal Investigator

Children's National Research Institute

Eligibility Criteria

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

Outcomes

Primary Outcomes

System set-up time

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

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

Study Sites (1)

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