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

NCT07798362 | Not Yet Recruiting

• 1 other identifier: HUB20260202
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Lung Nodule, Solitary; Lung Nodule; Lung Cancer (Diagnosis)

Keywords

bronchoscopy; iriscope; biopsy

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Study Arms (2)

Control group

OTHER

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.

Procedure: Bronchoscopy

Iriscope® group

EXPERIMENTAL

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.

Procedure: Use of Iriscope via guide sheath to guide biopsies

Interventions

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.

Iriscope® group

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasme University Hospital: lead
• Hôpital Civil Marie Curie de Charleroi: collaborator
• Hôpitaux IRIS Sud: collaborator

MeSH Terms

Conditions

Solitary Pulmonary Nodule; Lung Neoplasms; Disease

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Blandine Jelli

  Hôpitaux Universitaires de Bruxelles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Blandine Jelli

CONTACT

00325553943; blandine.jelli@hubruxelles.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 1, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share