Thin EBUS Pilot Study

NCT04745962 | Completed

• 1 other identifier: 00083498
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung; Node

Outcome Measures

Primary Outcomes (1)

• Ability to visualize lung nodule

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

  Throughout the procedure (approximately 1 hour)

Study Arms (1)

Procedural group

Device: Slimscope

Interventions

Slimscope DEVICE

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

Procedural group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients who are scheduled for standard of care assessment of central pulmonary nodules.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Olympus Corporation: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Study Officials

• Nicholas J Pastis, MD

  The Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 9, 2021
• Study Start: September 9, 2020
• Primary Completion: September 28, 2024
• Study Completion: September 28, 2024
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)