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Thin-EBUS in Ex-vivo Human Lungs

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ClinicalTrials.gov Identifier: NCT03349307
Recruitment Status : Recruiting
First Posted : November 21, 2017
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lung Cancer Device: Thin Convex Probe Endobronchial Ultrasound (TCP-EBUS) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility of the Thin Convex Probe Endobronchial Ultrasound (TCP-EBUS) System for Lymph Node Staging
Actual Study Start Date : July 12, 2017
Estimated Primary Completion Date : February 28, 2018
Estimated Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    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.


Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03349307


Contacts
Contact: Kimberley Hudson 416-581-7486 ext 18-7486 kimberley.hudson@uhn.ca
Contact: Judy McConnell 416-581-7486 ext 18-7486 judy.mcconnell@uhn.ca

Locations
Canada, Ontario
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Kimberley Hudson    416-581-7486    kimberley.hudson@uhn.ca   
Sponsors and Collaborators
University Health Network, Toronto

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03349307     History of Changes
Other Study ID Numbers: 16-6083
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators plan to share data at the time of manuscript publication.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Health Network, Toronto:
lobectomy