Thin-EBUS in Ex-vivo Human Lungs

May 7, 2018 updated by: University Health Network, Toronto

Feasibility of the Thin Convex Probe Endobronchial Ultrasound (TCP-EBUS) System for Lymph Node Staging

This study will determine the feasibility of the novel thin convex probe endobronchial ultrasound (TCP-EBUS) in human resected lobes. The primary end point is to clarify the feasibility of using the thin convex probe EBUS scope to visualize lung tumors from an intra-bronchial view. The secondary objective is to evaluate the insertion ability, operability, endoscopic image and ultrasound image compared to that of the convex probe EBUS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any patients scheduled for lobectomy or anatomical segmental resection for malignant lung tumors.
  • 18 years of age or older

Exclusion Criteria:

  • Any patients with inability to give informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: No Intervention
Device: Thin Convex Probe Endobronchial Ultrasound (TCP-EBUS)
Patients scheduled for a lobectomy will be recruited to this study and approached for informed consent. At the time of surgery, once the lobe has been removed, the TCP-EBUS will be inserted through a bronchial stamp for brief operability evaluations and image acquisition. Once this data has been captured standard of care will continue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To clarify the feasibility of using the thin convex probe EBUS scope to visualize lung tumors from an intra bronchial view.
Time Frame: Within an hour of resection.
The TCP-EBUS bronchoscope will be inserted through the endotracheal tube for visualization of lobar, segmental and sub segmental bronchi.
Within an hour of resection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2017

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

November 13, 2017

First Submitted That Met QC Criteria

November 16, 2017

First Posted (Actual)

November 21, 2017

Study Record Updates

Last Update Posted (Actual)

May 14, 2018

Last Update Submitted That Met QC Criteria

May 7, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 16-6083

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The investigators plan to share data at the time of manuscript publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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