nCLE For Diagnosis Of Peripheral Lung Nodules By Robotic Navigational Bronchoscopy

UnknownOBSERVATIONAL
Enrollment

25

Participants

Timeline

Start Date

June 29, 2020

Primary Completion Date

September 20, 2021

Study Completion Date

December 31, 2023

Conditions
Diagnosis of Peripheral Lung Nodules
Interventions
DEVICE

Images acquired by needle-based Confocal Laser Endomicroscopy (nCLE)

Patients who are scheduled to undergo Robotic Navigational Bronchoscopy for a peripheral lung lesion will be enrolled. During bronchoscopy, confocal images will be captured using Cellvizio 100 Series Confocal Laser Imaging systems and their Confocal Miniprobes (Mauna Kea Technologies Paris, France). The Cellvizio system and miniprobes are FDA approved by 510(k) for use in through the respiratory tracts by endoscopy or endoscopic accessories. Only images and needle aspiration/ biopsy results from the expansion phase (20 patients) will be analyzed

Trial Locations (2)

1105

Amsterdam University Medical Center, Amsterdam

19111

Fox Chase Cancer Center, Philadelphia

All Listed Sponsors
collaborator

Mauna Kea Technologies

INDUSTRY

collaborator

Johnson & Johnson

INDUSTRY

lead

Fox Chase Cancer Center

OTHER