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Completed

NCT Number: NCT05231278

Confocal Laser Endomicroscopy Nodule Localization by Robotic 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).

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Key information

Conditions

Lung Neoplasms Lung Diseases Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

John Muir Health, Concord, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nCLE aided RANB biospy

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Sensitivity of the real-time nCLE imaging assessment for malignancy

    Time frame: Intra-procedure

    The real-time nCLE imaging assessment of the index PPN for malignancy will be compared to the histopathology biopsy results of the index PPN.

  2. Diagnostic yield

    Time frame: up to 12 months post procedure

    Diagnostic yield for all nCLE aided RANB biopsy performed for the index PPN will be evaluated based on histopathological assessment of acquired tissue samples.

  3. Sensitivity of the post-procedure nCLE image assessment for malignancy

    Time frame: Intra-procedure

    The post-procedure nCLE image assessment of the index PPN for malignancy will be compared to the histopathology biopsy results of the index PPN.

  4. Intra- and inter-observer agreement of the post-procedure nCLE imaging for malignancy

    Time frame: Intra-procedure

    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.

  5. Safety of nCLE aided RANB biopsy procedure

    Time frame: up to 30 days post 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.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Enterprise Innovation Inc.

Industry

Registry information

Official study title

Needle-Based Confocal Laser Endomicroscopy to Aid in Lung Nodule Localization by Robotic-Assisted Navigational Bronchoscopy

Acronym: CLEAR

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 9, 2022
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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