Image Fusion in the OR

Not Applicable

Completed

• Conditions: Liver Ablation; Laparoscopic Cholecystectomy
• Interventions: Device: LapAR

• Registration Number: NCT03670849
• Lead Sponsor: Raj Shekhar

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.

Study Timeline

• Study First Submitted: 2018-09-12
• Study First Submitted QC: 2018-09-12
• Study First Posted: 2018-09-14
• Study Start: 2020-09-29
• Primary Completion: 2022-09-28
• Study Completion: 2022-10-28
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-01
• Last Update Posted: 2023-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients using LapAR system	LapAR	-

Primary Outcome Measures

Name	Time	Method
System set-up time	before surgery, an expected average of 15 min
Usability	post surgery, an expected average of 5 minutes	The ease of use of the LapAR system will be evaluated by the surgeon

Trial Locations

Locations (1)

Children's National Hospital; 🇺🇸 Washington, District of Columbia, United States