Assessment of Augmented Reality in Minimally Invasive Surgery

Not Applicable

• Conditions: Laparoscopic Hepatectomy; Laparoscopic Liver Thermal Ablation
• Interventions: Device: LapAR

• Registration Number: NCT03678220
• Lead Sponsor: IGI Technologies, Inc.

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.

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 Timeline

• Status Verified: 2018-09
• Study First Submitted: 2018-09-17
• Study First Submitted QC: 2018-09-17
• Study First Posted: 2018-09-19
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-26
• Study Start: 2019-04-01
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients using LapAR system	LapAR	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
System set-up time	before surgery, an expected average of 15 min

Trial Locations

Locations (1)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States