Status:

COMPLETED

Thin EBUS Pilot Study

Lead Sponsor:

Medical University of South Carolina

Collaborating Sponsors:

Olympus Medical Systems Corp., Tokyo, Japan.

Conditions:

Lung; Node

Eligibility:

All Genders

21+ years

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 c...

Eligibility Criteria

Inclusion

  • 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

  • Not suitable for flexible bronchoscopy as determined by the treating physician prior to the procedure.
  • Currently on anticoagulation medications with INR \>1.5.
  • 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.

Key Trial Info

Start Date :

September 9 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

September 28 2024

Estimated Enrollment :

51 Patients enrolled

Trial Details

Trial ID

NCT04745962

Start Date

September 9 2020

End Date

September 28 2024

Last Update

January 9 2025

Active Locations (1)

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Medical University of South Carolina

Charleston, South Carolina, United States, 29425