Thin EBUS Pilot Study

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Lung; Node

Treatments: Device: Slimscope

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04745962

00083498

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

51 participants in 1 patient group

Procedural group

Treatment:

Device: Slimscope