NCT03670849

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
2 years until next milestone

Study Start

First participant enrolled

September 29, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2022

Completed
Last Updated

March 2, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

September 12, 2018

Last Update Submit

March 1, 2023

Conditions

Laparoscopic CholecystectomyLiver Ablation

Keywords

Laparoscopic Ultrasound

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Patients using LapAR system

EXPERIMENTAL
Device: LapAR

Interventions

LapARDEVICE

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.

Patients using LapAR system

Eligibility Criteria

Age1 Year - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Referred for laparoscopic cholecystectomy or liver ablation
  • Clinical indication for the use of laparoscopic ultrasound
  • Patient or an authorized guardian provides written consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 12, 2018

First Posted

September 14, 2018

Study Start

September 29, 2020

Primary Completion

September 28, 2022

Study Completion

October 28, 2022

Last Updated

March 2, 2023

Record last verified: 2023-03

Locations

US(1)