Thin-EBUS in Ex-vivo Human Lungs

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thin Convex Probe Endobronchial Ultrasound (TCP-EBUS)

Device

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Nov 21, 2017
Registry last updated: May 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed