NCT07798362Not yet recruiting
Iriscope for the Diagnosis of Peripheral Pulmonary Lesions: a Multicentre Randomised Controlled Trial
Source: ClinicalTrials.gov · Last updated 1 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 27 Aug 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 30 Sept 2028
- Lead sponsor
- Erasme University Hospital
- Diseases
- Lung cancer
- NCT number
- NCT07798362
What you commit to
- Study type: Interventional
- Planned participants: 140
- From 1 Sept 2026 to the primary completion date, 30 Sept 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Uncorrected coagulation disorders (PT \< 50%, platelet count \< 50,000/mm³)
Other
- Intra-procedure discovery of an endobronchial lesion visible on conventional bronchoscopy (→ post hoc exclusion)
- Contraindication to bronchoscopy or to general or local anaesthesia
- Pregnancy or breastfeeding
- Simultaneous participation in another interventional clinical trial
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.