Assessment of Augmented Reality in Minimally Invasive Surgery

Clinical Translation of Augmented Reality Visualization for Laparoscopic Surgery

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03678220

Enrollment

Registered

2018-09-19

Start date

2019-04-01

Completion date

2020-03-01

Last updated

2019-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Hepatectomy, Laparoscopic Liver Thermal Ablation

Keywords

Laparoscopic Ultrasound

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.

Interventions

DEVICELapAR

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Contacts

Primary ContactRaj Shekhar, PhD

raj@igitechnologies.com202-476-1201

Backup ContactWilliam Plishker, PhD

will@igitechnologies.com202-713-9571

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026