Image Fusion in the OR

NCT ID: NCT03670849

Last Updated: 2023-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-29
• Study Completion Date: 2022-10-28

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.

We 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. For ablations, we further track the needle and overlay its path on the AR view for precise needle placement. This study is designed to test this minimal-risk capability in patients referred for relevant laparoscopic procedures.

Conditions

Laparoscopic Cholecystectomy; Liver Ablation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Patients using LapAR system

Group Type: EXPERIMENTAL

LapAR

Intervention Type: DEVICE

LapAR system will map (transform) the live LUS image in the reference frame of the laparoscopic camera, and fuse it with the live laparoscopic video in real time. For thermal ablations that involve a needle, we also track the needle and overlay its path on the AR view.

Interventions

LapAR

LapAR system will map (transform) the live LUS image in the reference frame of the laparoscopic camera, and fuse it with the live laparoscopic video in real time. For thermal ablations that involve a needle, we also track the needle and overlay its path on the AR view.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Referred for laparoscopic cholecystectomy or liver ablation

2. Clinical indication for the use of laparoscopic ultrasound

3. Patient or an authorized guardian provides written consent

Exclusion Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

IGI Technologies, Inc.

INDUSTRY

Sponsor Role: collaborator

Raj Shekhar

OTHER

Sponsor Role: lead

Responsible Party

Raj Shekhar

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Children's National Hospital

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

2R42CA192504

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00003344

Identifier Type: -

Identifier Source: org_study_id