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New laser tool may help doctors pinpoint lung nodules during biopsy

NCT ID NCT05231278

Diagnosis Sponsor: Johnson & Johnson Enterprise Innovation Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new imaging tool called needle-based confocal laser endomicroscopy (nCLE) to help doctors locate lung nodules during robotic-assisted bronchoscopy. 53 adults with lung nodules at risk for cancer took part. The goal was to see if the tool could safely and accurately confirm that the biopsy needle was in the right spot, potentially improving diagnosis.

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

53 people

The number who actually took part.

Started

Jan 2022

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

22 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 ≥ 22 years at signing of informed consent form (ICF). * Undergoing standard-of-care RANB for a solid lung nodule, which is considered to be at intermediate- to high-risk for malignancy as determined by the investigator per the institution's standard of care. * ICF signed before any study procedures are initiated. Exclusion Criteria: * Medical contraindication to bronchoscopy under general anesthesia, or lack of physical fitness to undergo bronchoscopy under general anesthesia or to follow the study processes, as assessed by the investigator. * Presence of uncorrectable bleeding disorders, or anticoagulation/anti-platelet aggregation therapy that cannot be withheld for an appropriate interval prior to the procedure, as defined per the institution's standard of care. * Medical devices interfering with electro-magnetic navigation, including but not limited to pacemakers. * Subjects who have a target lesion that shows endobronchial involvement on chest CT. * Participation in any other clinical trial within 30 days of enrollment, that would interfere with this study. * Known hypersensitivity to fluorescein sodium or any other ingredients in the fluorescein product. * Planned surgical resection at the time of bronchoscopy * Female subjects who are pregnant or nursing at the time of the procedure.

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Conditions

The condition(s) this trial relates to.

lung neoplasm

As listed by the trial registrant

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

Lung neoplasms

Contacts and locations

Locations

  • Clinical Research Associates of Central PA

    Altoona, Pennsylvania, 16602, United States

  • Fox Chase Cancer Center of the American Oncologic Hospital, Inc.

    Philadelphia, Pennsylvania, 19129, United States

  • John Muir Health

    Concord, California, 94520, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

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