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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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425