Thin-EBUS in Ex-vivo Human Lungs

NCT03349307 | Completed

• 1 other identifier: 16-6083
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

lobectomy

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

No Intervention

EXPERIMENTAL

Device: Thin Convex Probe Endobronchial Ultrasound (TCP-EBUS)

Interventions

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.

No Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Any patients with inability to give informed consent.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: November 21, 2017
• Study Start: July 12, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 14, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)