Thin-EBUS in Ex-vivo Human Lungs

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03349307
• Other study ID #: 16-6083
• Status: Completed
• Phase: N/A
• Start date: July 12, 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: May 2018
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer

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.

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To clarify the feasibility of using the thin convex probe EBUS scope to visualize lung tumors from an intra bronchial view.	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.