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OpenTrials
Completed

NCT Number: NCT04745962

Thin EBUS Pilot Study

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.

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Key information

Conditions

Lung; Node

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Slimscope

Device

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

Primary outcomes

  1. Ability to visualize lung nodule

    Time frame: Throughout the procedure (approximately 1 hour)

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

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • Olympus Corporation

Registry information

Official study title

Clinical Evaluation of the Thin TCP-EBUS Bronchoscopy System

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Feb 9, 2021
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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