Thin EBUS Pilot Study

Medical University of South Carolina51 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Lung; Node

Interventions

SlimscopeDEVICE

Slimscope thin EBUS endoscope is inserted and used to visualize lung nodules.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Willing and able to provide informed consent. 2. \>21 years of age or older. 3. 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. 4. Target lesion(s) location documented on CT scan report. 5. Indicated for bronchosocpy. 6. Bronchoscopic procedure scheduled within 30 days of the CT scan report. Exclusion Criteria: 1. Not suitable for flexible bronchoscopy as determined by the treating physician prior to the procedure. 2. Currently on anticoagulation medications with INR \>1.5. 3. Currently using DOAC and does not suspend use at least 7 days prior to the index procedure 4. Currently using Plavix and does not suspend use for at least 7 days prior to the index procedure.

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

Ability to visualize lung nodule

Study team will determine whether or not the lung nodule was able to be visualized by the scope.

Time frame: Throughout the procedure (approximately 1 hour)

Data from ClinicalTrials.gov

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