Status:
COMPLETED
Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy
Lead Sponsor:
Johnson & Johnson Enterprise Innovation Inc.
Conditions:
Lung Neoplasms
Eligibility:
All Genders
22+ years
Phase:
NA
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) bi...
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 bronch...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2024
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT05231278
Start Date
January 20 2022
End Date
September 6 2024
Last Update
April 25 2025
Active Locations (4)
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1
John Muir Health
Concord, California, United States, 94520
2
Clinical Research Associates of Central PA
Altoona, Pennsylvania, United States, 16602
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
4
Fox Chase Cancer Center of the American Oncologic Hospital, Inc.
Philadelphia, Pennsylvania, United States, 19129