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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04745962
Other study ID # 00083498
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


Related Conditions & MeSH terms


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)
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