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Thin EBUS Pilot Study

Clinical Evaluation of the Thin TCP-EBUS Bronchoscopy System

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04745962
Enrollment
51
Registered
2021-02-09
Start date
2020-09-09
Completion date
2024-09-28
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung; Node

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 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.

Interventions

DEVICESlimscope

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

Sponsors

Medical University of South Carolina
Lead SponsorOTHER
Olympus Corporation
CollaboratorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Ability to visualize lung noduleThroughout the procedure (approximately 1 hour)Study team will determine whether or not the lung nodule was able to be visualized by the scope.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORNicholas J Pastis, MD

The Medical University of South Carolina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026