NCT05231278

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 9, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2024

Completed
Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

1.7 years

First QC Date

January 28, 2022

Last Update Submit

May 8, 2026

Conditions

Lung Neoplasms

Keywords

Peripheral pulmonary noduleNeedle-based confocal laser endomicroscopyRobotic-assisted bronchoscopyMonarch

Outcome Measures

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)

    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 Outcomes (5)

  • Sensitivity of the real-time nCLE imaging assessment for malignancy

    Intra-procedure

  • Diagnostic yield

    up to 12 months post procedure

  • Sensitivity of the post-procedure nCLE image assessment for malignancy

    Intra-procedure

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

    Intra-procedure

  • Safety of nCLE aided RANB biopsy procedure

    up to 30 days post procedure

Study Arms (1)

nCLE aided RANB biopsy

EXPERIMENTAL

Single arm study

Device: nCLE aided RANB biospy

Interventions

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.

nCLE aided RANB biopsy

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

John Muir Health

Concord, California, 94520, United States

Location

Clinical Research Associates of Central PA

Altoona, Pennsylvania, 16602, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

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

Philadelphia, Pennsylvania, 19129, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Balaji Laxmanan, MD

    Johnson & Johnson Enterprise Innovation Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2022

First Posted

February 9, 2022

Study Start

January 20, 2022

Primary Completion

October 12, 2023

Study Completion

September 6, 2024

Last Updated

May 13, 2026

Record last verified: 2026-05

Locations

US(4)