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.

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Key information

Conditions

Lung Nodule, Solitary Disease Lung Cancer (Diagnosis) Lung Diseases Lung Neoplasms Lung Nodule Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Solitary Pulmonary Nodule Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of Iriscope via guide sheath to guide biopsies

Procedure

The Iriscope® probe (diameter 1.3 mm, CE-marked device, Lys Medical, Belgium) will be introduced via a guide sheath into the working channel of the bronchoscope towards the bronchus leading to the target lesion. Correct positioning will be confirmed by concordance between fluoroscopic guidance and endobronchial mucosal abnormalities observed through the Iriscope®. Once satisfactory positioning is confirmed, the Iriscope® probe will be withdrawn and biopsies will be performed through the guide sheath according to the standard routine procedure. In cases where the lesion is not visible under fluoroscopy, guidance will rely exclusively on Iriscope® visualisation.

Bronchoscopy

Procedure

Bronchoscopy will be performed under fluoroscopic guidance according to the standardised technique described by Ost et al. (AQUIRE registry, Am J Respir Crit Care Med, 2016), without use of Iriscope®. This is the routine procedure currently practised at all participating centres.

Primary outcomes

Diagnostic yield of bronchoscopy, defined as the proportion of patients in whom the endoscopic procedure - a routine procedure at all four centres - established a specific benign or malignant diagnosis, relative to the total number of patients who underw

Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Blandine Jelli

CONTACT

[email protected]

00325553943

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Collaborators

Hôpital Civil Marie Curie de Charleroi
Hôpitaux IRIS Sud

Registry information

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Sep 1, 2026
Registry last updated: Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Active, not recruiting