Image Fusion in the OR

Raj Shekhar

Status: Completed

Conditions: Laparoscopic Cholecystectomy; Liver Ablation

Treatments: Device: LapAR

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT03670849

Pro00003344

2R42CA192504 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 1 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Patients using LapAR system

Experimental group

Treatment:

Device: LapAR