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Can a tiny camera help doctors diagnose lung nodules more accurately?

NCT ID NCT07798362

Diagnosis Sponsor: Erasme University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This trial tests whether adding a small probe called the Iriscope to standard bronchoscopy improves the diagnosis of lung nodules. Doctors usually guide the biopsy with real-time X-rays, but sometimes they cannot see the nodule directly. The Iriscope slides into the bronchoscope and lets doctors see the inside of the small airways and the nodule itself. The study compares the rate of correct diagnosis between bronchoscopy guided by X-rays alone and bronchoscopy guided by both X-rays and the Iriscope.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Iriscope, a small probe that lets doctors see inside the airways during bronchoscopy
What this could lead to
If it works, this could make bronchoscopy more accurate for diagnosing lung nodules, reducing the need for repeat procedures or more invasive tests.
What could go wrong
The trial is relatively small and early, and the benefit over standard fluoroscopy may be modest. The device adds a step to the procedure, and there is a small risk of complications from the biopsy itself.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

disease lung cancer lung neoplasm pulmonary coin lesion

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lung cancer (diagnosis) Lung nodule Lung nodule, solitary

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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