Iriscope for the Diagnosis of Peripheral Pulmonary Lesions: a Multicentre Randomised Controlled Trial

A pulmonary nodule is a small mass detected in your lungs during a scan. When a nodule issuspicious, we need to determine its nature (benign or malignant). To do this, abronchoscopy is performed.Bronchoscopy is a common examination. It involves inserting a thin, flexible tube (thebronchoscope) into the airways to take tissue samples (biopsies) from the nodule. Thisexamination is routinely performed in the hospitals participating in this study.Currently, bronchoscopy is guided by fluoroscopy, a type of real‐time X‐ray imaging.However, sometimes we are unable to directly see the nodule, which can reduce the chancesof obtaining an accurate diagnosis.The Iriscope is a small device, 1.3 mm in diameter, that slides into the bronchoscope. Itallows direct visualization of the inside of the small bronchi and the nodule. Itspurpose is to help us navigate more precisely and thus obtain a better diagnosis.The Iriscope carries the CE mark. This mark guarantees that it meets European safetystandards for medical devices.The purpose of this study is to compare the rate of correct diagnosis betweenbronchoscopy guided by fluoroscopy alone and bronchoscopy guided by a combination offluoroscopy and the Iriscope.