Thin EBUS Pilot Study

Lung; Node Clinical Trial

Official title:

Clinical Evaluation of the Thin TCP-EBUS Bronchoscopy System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04745962
• Other study ID #: 00083498
• Status: Recruiting
• Start date: September 9, 2020
• Est. completion date: January 30, 2025

Study information

• Verified date: January 2024
• Source: Medical University of South Carolina
• Contact: Michael F Balassone, BS
• Phone: 843-792-6696
• Email: Balassom[@]musc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 30, 2025
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung; Node

Intervention

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

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	Olympus Medical Systems Corp., Tokyo, Japan.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)