Assessment of Augmented Reality in Minimally Invasive Surgery

Laparoscopic Hepatectomy Clinical Trial

Official title:

Clinical Translation of Augmented Reality Visualization for Laparoscopic Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03678220
• Other study ID #: LAPAR01
• Secondary ID: 2R42CA192504
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: September 2018
• Source: IGI Technologies, Inc.
• Contact: Raj Shekhar, PhD
• Phone: 202-476-1201
• Email: raj[@]igitechnologies.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopic Hepatectomy
• Laparoscopic Liver Thermal Ablation

Intervention

Device:
• LapAR
LapAR system will be used for guidance during laparoscopic hepatectomy and laparoscopic liver thermal ablation

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
IGI Technologies, Inc.	National Cancer Institute (NCI), National Institutes of Health (NIH), University of Pittsburgh Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Procedure time	Time of using the LapAR system for laparoscopic hepatectomy and laparoscopic thermal ablation	during surgery
Primary	Measurement of margin	Obtain from Pathology department or follow-up imaging	post surgery
Secondary	System set-up time		before surgery, an expected average of 15 min