NCT02146131

Ultrathin Bronchoscope and Radial Endobronchial Ultrasound (R-EBUS) With Fluoroscopy Versus Standard Fiberoptic Bronchoscopy (FB) (P00029233 )

Multicenter, Prospective, Randomized Trial of Bronchoscopy With Ultrathin Bronchoscope and Radial Endobronchial Ultrasound (R-EBUS) With Fluoroscopy Versus Standard Fiberoptic Bronchoscopy (FB) With Fluoroscopy for Biopsy of Pulmonary Lesions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 339 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the yield of two methods for obtaining a lung tissue sample: Procedure #1: standard fiberoptic bronchoscopy (FB) with fluoroscopy, and Procedure #2: ultrathin bronchoscope procedure with fluoroscopy and radial endobronchial ultrasound (R-EBUS). These two procedures are similar in that they both: (1) enable your doctor to look inside your lungs with a device called a bronchoscope, and (2) Use fluoroscopy, which is a technique that uses X-rays to see your lungs. This will give the doctor an opportunity to use either of the bronchoscopy methods described above and compare the tests to see if R-EBUS provides better results than standard bronchoscopy.

Conditions

• Pulmonary Lesions
• Pulmonary Nodules
• Pulmonary Mass

Interventions

Type	Name	Description
DEVICE	Standard FB with fluoroscopy	Technique used, to go through the patient's airway, locate and obtain samples from pulmonary lesions
DEVICE	R-EBUS with ultrathin bronchoscope	Technique used to go through the patient's airway and using radial ultrasound, locate and obtain samples from pulmonary lesions

Timeline

• Start date: 2014-07-01
• Primary completion: 2017-07-14
• Completion: 2017-07-14
• First posted: 2014-05-23
• Last updated: 2018-09-25
• Results posted: 2018-09-25

Locations

5 sites across 1 country: United States