Image Fusion in the OR | NCT03670849

Studies
Image Fusion in the OR

NCT03670849

Sponsor

Raj Shekhar

Status

Completed

Last Update Posted

Mar 2, 2023Actual

Enrollment

11Actual

Phase

Not Applicable

Conditions

Laparoscopic Cholecystectomy
Liver Ablation

Interventions

LapAR

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2R42CA192504	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 29, 2020Actual

Primary Completion Date

Sep 28, 2022Actual

Completion Date

Oct 28, 2022Actual

First Submitted Date

Sep 12, 2018

First Submission Date that Met QC Criteria

Sep 12, 2018

First Posted Date

Sep 14, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2023

Last Update Posted Date

Mar 2, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Raj Shekhar, Principal Investigator, Children's National Research InstituteSponsor-Investigator

Lead Sponsor

Raj ShekharOTHER

Collaborators

Name	Class
National Institutes of Health (NIH)	NIH
National Cancer Institute (NCI)	NIH
IGI Technologies, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients using LapAR system	Experimental		Device: LapAR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LapAR	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Referred for laparoscopic cholecystectomy or liver ablation
Clinical indication for the use of laparoscopic ultrasound
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's National Hospital		Washington D.C.	District of Columbia	20010	United States