Lung Nodule, SolitaryNCT07798362
Iriscope for the Diagnosis of Peripheral Pulmonary Lesions: a Multicentre Randomised Controlled Trial
A study testing Use of Iriscope via guide sheath to guide biopsies and Bronchoscopy in people with Lung Nodule, Solitary and Lung Nodule, run by Erasme University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Nodule, Solitary, Lung Nodule, Lung Cancer (Diagnosis)
- What is being tested?
- Use of Iriscope via guide sheath to guide biopsies and Bronchoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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)
- Being tested
- Use of Iriscope via guide sheath to guide biopsies, Bronchoscopy
- Keywords
- bronchoscopy, iriscope, biopsy
- Medical subject headings
- Solitary Pulmonary Nodule, Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Iriscope via guide sheath to guide biopsiesProcedure or 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.
BronchoscopyProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Use of Iriscope via guide sheath to guide biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Nodule, SolitaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital Civil Marie Curie de Charleroi, Hôpitaux IRIS Sud
- Responsible party
- Principal investigator, Blandine Jelli, Erasme University Hospital
- Investigators
- Blandine Jelli, Principal investigator, Hôpitaux Universitaires de Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798362
- Sponsor's protocol ID
- HUB20260202
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iriscope for the Diagnosis of Peripheral Pulmonary Lesions: a Multicentre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07798362
- Acronym / sponsor ID
- HUB20260202
- Conditions
- Lung Nodule, Solitary, Lung Nodule, Lung Cancer (Diagnosis)
- Keywords
- bronchoscopy, iriscope, biopsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Collaborators
- Hôpital Civil Marie Curie de Charleroi, Hôpitaux IRIS Sud
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Procedure: BronchoscopyBronchoscopy 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. |
| Iriscope® group | Experimental | Procedure: Use of Iriscope via guide sheath to guide biopsiesThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of Iriscope via guide sheath to guide biopsiesThe 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 or surgery | Iriscope® group |
| BronchoscopyBronchoscopy 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 or surgery | Control group |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Blandine Jelli principal investigator
Hôpitaux Universitaires de Bruxelles
Questions about this trial
What is this clinical trial studying?
A study testing Use of Iriscope via guide sheath to guide biopsies and Bronchoscopy in people with Lung Nodule, Solitary and Lung Nodule, run by Erasme University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Blandine Jelli (00325553943, blandine.jelli@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.