Assessment of Augmented Reality in Minimally Invasive Surgery

NCT ID: NCT03678220

Last Updated: 2019-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-03-01

Brief Summary

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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

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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.

Conditions

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Laparoscopic Hepatectomy Laparoscopic Liver Thermal Ablation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Patients using LapAR system

Group Type EXPERIMENTAL

LapAR

Intervention Type DEVICE

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

Interventions

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LapAR

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Pittsburgh Medical Center

OTHER

Sponsor Role collaborator

IGI Technologies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Central Contacts

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Raj Shekhar, PhD

Role: CONTACT

202-476-1201

William Plishker, PhD

Role: CONTACT

202-713-9571

Facility Contacts

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David Geller, MD

Role: primary

412-692-2001

Other Identifiers

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2R42CA192504

Identifier Type: NIH

Identifier Source: secondary_id

View Link

LAPAR01

Identifier Type: -

Identifier Source: org_study_id

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