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

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 is suspicious, we need to determine its nature (benign or malignant). To do this, a bronchoscopy is performed.

Bronchoscopy is a common examination. It involves inserting a thin, flexible tube (the bronchoscope) into the airways to take tissue samples (biopsies) from the nodule. This examination 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 chances of obtaining an accurate diagnosis.

The Iriscope is a small device, 1.3 mm in diameter, that slides into the bronchoscope. It allows direct visualization of the inside of the small bronchi and the nodule. Its purpose 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 safety standards for medical devices.

The purpose of this study is to compare the rate of correct diagnosis between bronchoscopy guided by fluoroscopy alone and bronchoscopy guided by a combination of fluoroscopy and the Iriscope.

Inclusion Criteria:

• Age ≥ 18 years
• Peripheral pulmonary lesion of 20 to 50 mm in diameter on a recent chest CT scan (< 3 months)
• Suspicion of malignancy justifying endoscopic investigation
• Diagnostic bronchoscopy scheduled as routine at one of the four participating centres
• Written informed consent obtained
• Ability to understand and sign the consent form (in French or with a certified interpreter)

Exclusion Criteria:

• Intra-procedure discovery of an endobronchial lesion visible on conventional bronchoscopy (→ post hoc exclusion)
• Contraindication to bronchoscopy or to general or local anaesthesia
• Uncorrected coagulation disorders (PT < 50%, platelet count < 50,000/mm³)
• Pregnancy or breastfeeding
• Simultaneous participation in another interventional clinical trial