Clinical Evaluation of the Thin TCP-EBUS Bronchoscopy System

Medical University of South Carolina1 site in 1 country51 target enrollmentSeptember 9, 2020

ConditionsLung; Node

InterventionsSlimscope

Overview

Phase: Not Applicable
Intervention: Slimscope
Conditions: Lung; Node
Sponsor: Medical University of South Carolina
Enrollment: 51
Locations: 1
Primary Endpoint: Ability to visualize lung nodule
Status: Completed
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single-center pilot study at the Medical University of South Carolina (MUSC) to evaluate the safety and efficacy of the TCP-EBUS scope (Thin EBUS). This study will consist of a standard of care bronchoscopy and will be followed for approximately 3 months. While the device is not FDA approved, it is the same technology but a thinner version of the SCP-EBUS bronchoscope.

Registry

clinicaltrials.gov

Start Date

September 9, 2020

End Date

September 28, 2024

Last Updated

2 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Medical University of South Carolina

Responsible Party

Sponsor

Principal Investigator

Gerard Silvestri, MD

Professor of Medicine

Medical University of South Carolina

Eligibility Criteria

Inclusion Criteria

•Willing and able to provide informed consent.
•\>21 years of age or older.
•Target lesion(s) within the middle third of the lung, which will be determined radiographically prior to scheduling the procedure by the bronchoscopist or radiologist, or by being located at least 2 airway generations from the main carina as seen radiographically.
•Target lesion(s) location documented on CT scan report.
•Indicated for bronchosocpy.
•Bronchoscopic procedure scheduled within 30 days of the CT scan report.

Exclusion Criteria

•Not suitable for flexible bronchoscopy as determined by the treating physician prior to the procedure.
•Currently on anticoagulation medications with INR \>1.
•Currently using DOAC and does not suspend use at least 7 days prior to the index procedure
•Currently using Plavix and does not suspend use for at least 7 days prior to the index procedure.