Assessment of Augmented Reality in Minimally Invasive Surgery

Clinical Translation of Augmented Reality Visualization for Laparoscopic Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Laparoscopic Hepatectomy; Laparoscopic Liver Thermal Ablation
• Intervention / Treatment: Device: LapAR

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.

The investigators 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: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raj Shekhar, PhD; Phone Number: 202-476-1201; Email: raj@igitechnologies.com
• Study Contact Backup: Name: William Plishker, PhD; Phone Number: 202-713-9571; Email: will@igitechnologies.com

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh Medical Center
      • Contact: David Geller, MD; Phone Number: 412-692-2001; Email: gellerda@upmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient is referred for either laparoscopic partial hepatectomy for tumor removal or laparoscopic ablation of liver cancer;
2. Patient must be at least 18 years old;
3. Patient provides written consent;
4. Patient is considered a suitable candidate based on tumor location for using the AR system.

Exclusion Criteria:

Patients with pacemaker or any other ICD(intra-cardiac device) which may interfere with electromagnetic tracking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients using LapAR system	Device: LapAR; LapAR system will be used for guidance during laparoscopic hepatectomy and laparoscopic liver thermal ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgeon interview regarding usability	The ease of use of the LapAR system will be evaluated by the surgeon	post surgery, an expected average of 5 minutes
Procedure time	Time of using the LapAR system for laparoscopic hepatectomy and laparoscopic thermal ablation	during surgery
Measurement of margin	Obtain from Pathology department or follow-up imaging	post surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
System set-up time	before surgery, an expected average of 15 min

Collaborators and Investigators

• Sponsor: IGI Technologies, Inc.
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH); University of Pittsburgh Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2019
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: September 17, 2018
• First Submitted That Met QC Criteria: September 17, 2018
• First Posted (Actual): September 19, 2018

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Laparoscopic Ultrasound
• Other Study ID Numbers: LAPAR01; 2R42CA192504 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No