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Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy

NCT05231278 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2026-05-13

No results posted yet for this study

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).

Conditions

  • Lung Neoplasms

Interventions

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.

Sponsors & Collaborators

  • Johnson & Johnson Enterprise Innovation Inc.

    lead INDUSTRY

Principal Investigators

  • Balaji Laxmanan, MD · Johnson & Johnson Enterprise Innovation Inc.

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-20
Primary Completion
2023-10-12
Completion
2024-09-06
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05231278 on ClinicalTrials.gov