Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy (CLEAR)

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).

Study Overview

• Status: Completed
• Conditions: Lung Neoplasms
• Intervention / Treatment: Device: nCLE aided RANB biospy

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 Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Concord, California, United States, 94520
      • John Muir Health
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • Clinical Research Associates of Central PA
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19129
      • Fox Chase Cancer Center of the American Oncologic Hospital, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nCLE aided RANB biopsy; Single arm study	Device: nCLE aided RANB biospy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Intra-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	up to 30 days post procedure

Collaborators and Investigators

• Sponsor: Johnson & Johnson Enterprise Innovation Inc.
• Investigators: Study Director: Balaji Laxmanan, MD, Johnson & Johnson Enterprise Innovation Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Actual): October 12, 2023
• Study Completion (Actual): September 6, 2024

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: January 28, 2022
• First Posted (Actual): February 9, 2022

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Monarch; Peripheral pulmonary nodule; Needle-based confocal laser endomicroscopy; Robotic-assisted bronchoscopy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: JJEI202101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes