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

August 27, 2026 updated by: Blandine Jelli, Erasme University Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group
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
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.
Experimental: Iriscope® group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasme University Hospital

Collaborators

Hôpitaux IRIS Sud
Hôpital Civil Marie Curie de Charleroi

Investigators

  • Principal Investigator: Blandine Jelli, Hôpitaux Universitaires de Bruxelles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

August 27, 2026

First Submitted That Met QC Criteria

August 27, 2026

First Posted (Actual)

September 1, 2026

Study Record Updates

Last Update Posted (Actual)

September 1, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUB20260202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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