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

ConditionsLung Nodule, Solitary Lung Nodule Lung Cancer (Diagnosis)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorErasme University Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Use of Iriscope via guide sheath to guide biopsies
Procedure/Surgery
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/Surgery
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.

Treatment groups

140 Participants

are divided into 2 treatment groups

Group A: Control groupOther 1 intervention

Group B: Iriscope® groupExperimental treatment 1 intervention

Trial outcomes

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Erasme University Hospital

Lead sponsor

Hôpital Civil Marie Curie de Charleroi

Collaborator

Hôpitaux IRIS Sud