Image Fusion in the OR

Laparoscopic Cholecystectomy Clinical Trial

Official title:

Ultrasound Augmentation of Stereoscopic and Conventional Video for Laparoscopic Surgeries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03670849
• Other study ID #: Pro00003344
• Secondary ID: 2R42CA192504
• Status: Completed
• Phase: N/A
• Start date: September 29, 2020
• Est. completion date: October 28, 2022

Study information

• Verified date: March 2023
• Source: Children's National Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 28, 2022
• Est. primary completion date: September 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Children's National Hospital	Washington	District of Columbia

Sponsors (4)

Lead Sponsor	Collaborator
Raj Shekhar	IGI Technologies, Inc., National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usability	The ease of use of the LapAR system will be evaluated by the surgeon	post surgery, an expected average of 5 minutes
Primary	System set-up time		before surgery, an expected average of 15 min