Lung NeoplasmsCLEARNCT05231278
Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy
A study testing nCLE aided RANB biospy in people with Lung Neoplasms, run by Johnson & Johnson Enterprise Innovation Inc. at 4 sites in United States.
Trial summary
This study is designed to evaluate the safety and feasibility of real-time needle-based confocal laser endomicroscopy (nCLE) in improving diagnostic accuracy of robotic-assisted bronchoscopy (RANB) biopsy performed with the Monarch® Endoscopy Platform in patients with peripheral pulmonary nodules (PPN). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- nCLE aided RANB biospy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 Jan 2022to 6 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Clinical Research Associates of Central PA
Altoona, Pennsylvania, 16602
John Muir Health
Concord, California, 94520
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Fox Chase Cancer Center of the American Oncologic Hospital, Inc.
Philadelphia, Pennsylvania, 19129
About this study
Official title: Needle-Based Confocal Laser Endomicroscopy to Aid in Lung Nodule Localization by Robotic-Assisted Navigational Bronchoscopy
This study is designed to evaluate the safety and feasibility of real-time needle-based confocal laser endomicroscopy (nCLE) in improving diagnostic accuracy of robotic-assisted bronchoscopy (RANB) biopsy performed with the Monarch® Endoscopy Platform in patients with peripheral pulmonary nodules (PPN).
Read the detailed description
Robotic-assisted navigational bronchoscopy (RANB) improves accuracy of lesion localization and diagnostic yield of the peripheral pulmonary nodule (PPN) biopsy compared to conventional flexible bronchoscopy. Needle based confocal laser endomicroscopy (nCLE) allows real-time microstructural imaging of lung nodule tissues at the needle tip. The study is designed to evaluate the safety and feasibility of utilizing nCLE during RANB biopsy procedure to optimize needle position and diagnostic accuracy, as well as reduce or replace the need for additional imaging tools such as radial endobronchial ultrasound (r-EBUS), cone beam computed tomography (CBCT), and/or fluoroscopy during RANB biopsy.
- Conditions
- Lung Neoplasms
- Being tested
- nCLE aided RANB biospy
- Keywords
- Peripheral pulmonary nodule, Needle-based confocal laser endomicroscopy, Robotic-assisted bronchoscopy, Monarch
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nCLE aided RANB biospyDevice
nCLE aided RANB biopsy procedure using the Monarch® robotic-assisted navigational bronchoscopy platform and Cellvizio® I.V.E. system with AQ-Flex™ 19 Confocal Miniprobe™ used in combination with Fluorescein.
| Study group | Role | What they receive |
|---|---|---|
| nCLE aided RANB biopsy | Experimental | Single arm study Receives: Device: nCLE aided RANB biospy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as Assessed by Proportion of Participants with Accurate 'Tool-in-lesion' Position During Needle-based Confocal Laser Scanning Endomicroscopy (nCLE)-Aided Robotic-Assisted Navigational Bronchoscopy (RANB)
Cone-beam computed tomography (CBCT) is used to determine the accuracy of the 'tool-in-lesion' position as obtained during nCLE-aided bronchoscopy.
Measured: Intra-procedure
Secondary outcomes (5)
Sensitivity of the real-time nCLE imaging assessment for malignancy
The real-time nCLE imaging assessment of the index PPN for malignancy will be compared to the histopathology biopsy results of the index PPN.
Measured: Intra-procedure
Diagnostic yield
Diagnostic yield for all nCLE aided RANB biopsy performed for the index PPN will be evaluated based on histopathological assessment of acquired tissue samples.
Measured: up to 12 months post procedure
Sensitivity of the post-procedure nCLE image assessment for malignancy
The post-procedure nCLE image assessment of the index PPN for malignancy will be compared to the histopathology biopsy results of the index PPN.
Measured: Intra-procedure
Intra- and inter-observer agreement of the post-procedure nCLE imaging for malignancy
The post-procedure nCLE image assessment of the index PPN will be obtained by multiple independent, blinded raters; the intra- and interobserver agreement will be determined.
Measured: Intra-procedure
Safety of nCLE aided RANB biopsy procedure
The safety of nCLE aided RANB biopsy procedure will be reported as the number and frequency of adverse events (AEs) and procedure-related AEs.
Measured: up to 30 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start20 Jan 2022
- Primary completion12 Oct 2023
- Study completion6 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Enterprise Innovation Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Balaji Laxmanan, MD, Study director, Johnson & Johnson Enterprise Innovation Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231278
- Sponsor's protocol ID
- JJEI202101
- Acronym
- CLEAR
- Status last verified
- May 2026
- First submitted
- 28 Jan 2022
- Last updated
- 13 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Needle-Based Confocal Laser Endomicroscopy to Aid in Lung Nodule Localization by Robotic-Assisted Navigational Bronchoscopy
- ClinicalTrials.gov ID
- NCT05231278
- Acronym / sponsor ID
- CLEAR / JJEI202101
- Conditions
- Lung Neoplasms
- Keywords
- Peripheral pulmonary nodule, Needle-based confocal laser endomicroscopy, Robotic-assisted bronchoscopy, Monarch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Johnson & Johnson Enterprise Innovation Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 12 Oct 2023 (actual)
- Study completion
- 6 Sep 2024 (actual)
- First posted
- 9 Feb 2022 (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.
This study is designed to evaluate the safety and feasibility of real-time needle-based confocal laser endomicroscopy (nCLE) in improving diagnostic accuracy of robotic-assisted bronchoscopy (RANB) biopsy performed with the Monarch® Endoscopy Platform in patients with peripheral pulmonary nodules (PPN).
Detailed description
Robotic-assisted navigational bronchoscopy (RANB) improves accuracy of lesion localization and diagnostic yield of the peripheral pulmonary nodule (PPN) biopsy compared to conventional flexible bronchoscopy. Needle based confocal laser endomicroscopy (nCLE) allows real-time microstructural imaging of lung nodule tissues at the needle tip. The study is designed to evaluate the safety and feasibility of utilizing nCLE during RANB biopsy procedure to optimize needle position and diagnostic accuracy, as well as reduce or replace the need for additional imaging tools such as radial endobronchial ultrasound (r-EBUS), cone beam computed tomography (CBCT), and/or fluoroscopy during RANB biopsy.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nCLE aided RANB biopsy | Experimental | Device: nCLE aided RANB biospySingle arm study |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| nCLE aided RANB biospynCLE aided RANB biopsy procedure using the Monarch® robotic-assisted navigational bronchoscopy platform and Cellvizio® I.V.E. system with AQ-Flex™ 19 Confocal Miniprobe™ used in combination with Fluorescein. | Device | nCLE aided RANB biopsy |
Primary outcome
Feasibility as Assessed by Proportion of Participants with Accurate 'Tool-in-lesion' Position During Needle-based Confocal Laser Scanning Endomicroscopy (nCLE)-Aided Robotic-Assisted Navigational Bronchoscopy (RANB)
Time frame: Intra-procedure
Cone-beam computed tomography (CBCT) is used to determine the accuracy of the 'tool-in-lesion' position as obtained during nCLE-aided bronchoscopy.
5 secondary outcomes
Sensitivity of the real-time nCLE imaging assessment for malignancy
Time frame: Intra-procedure
Diagnostic yield
Time frame: up to 12 months post procedure
Sensitivity of the post-procedure nCLE image assessment for malignancy
Time frame: Intra-procedure
Intra- and inter-observer agreement of the post-procedure nCLE imaging for malignancy
Time frame: Intra-procedure
Safety of nCLE aided RANB biopsy procedure
Time frame: up to 30 days post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
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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. This study is not recruiting at the moment.
Balaji Laxmanan, MD study director
Johnson & Johnson Enterprise Innovation Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nCLE aided RANB biospy in people with Lung Neoplasms, run by Johnson & Johnson Enterprise Innovation Inc. at 4 sites in United States.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as Assessed by Proportion of Participants with Accurate 'Tool-in-lesion' Position During Needle-based Confocal Laser Scanning Endomicroscopy (nCLE)-Aided Robotic-Assisted Navigational Bronchoscopy (RANB) (time frame: Intra-procedure). 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 13 May 2026.