NCT03678220

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

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
unknown

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 17, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

February 26, 2019

Status Verified

September 1, 2018

Enrollment Period

11 months

First QC Date

September 17, 2018

Last Update Submit

February 25, 2019

Conditions

Laparoscopic HepatectomyLaparoscopic Liver Thermal Ablation

Keywords

Laparoscopic Ultrasound

Outcome Measures

Primary Outcomes (3)

  • Surgeon interview regarding usability

    The ease of use of the LapAR system will be evaluated by the surgeon

    post surgery, an expected average of 5 minutes

  • Procedure time

    Time of using the LapAR system for laparoscopic hepatectomy and laparoscopic thermal ablation

    during surgery

  • Measurement of margin

    Obtain from Pathology department or follow-up imaging

    post surgery

Secondary Outcomes (1)

  • 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 be used for guidance during laparoscopic hepatectomy and laparoscopic liver thermal ablation

Patients using LapAR system

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is referred for either laparoscopic partial hepatectomy for tumor removal or laparoscopic ablation of liver cancer;
  • Patient must be at least 18 years old;
  • Patient provides written consent;
  • Patient is considered a suitable candidate based on tumor location for using the AR system.

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)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15260, United States

Location

Central Study Contacts

Raj Shekhar, PhD

CONTACT

202-476-1201raj@igitechnologies.com

William Plishker, PhD

CONTACT

202-713-9571will@igitechnologies.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2018

First Posted

September 19, 2018

Study Start

April 1, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

February 26, 2019

Record last verified: 2018-09

Locations

US(1)