CompletedNot Applicable

Thin EBUS Pilot Study

United States51 participantsStarted 2020-09-09

Plain-language 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.

Who can participate

Age range21 Years

SexALL

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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 \>1.5.
✕. 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.

What they're measuring

Ability to visualize lung nodule

Timeframe: Throughout the procedure (approximately 1 hour)

Trial details

NCT IDNCT04745962

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-09-28

View on ClinicalTrials.gov More Lung; Node trials