The Olympus BF-UCP190F bronchoscope combines the reach of a thinner bronchoscope with the benefit of real-time ultrasound, enabling direct lesion visualization and sampling deeper into the lung. Following promising first-in-human data, the LUCENT study aims to evaluate the utility feasibility, effectiveness and safety of this device in a multicenter setting, generating real-world evidence to inform broader adoption in global markets.
Willing and able to provide informed consent.
≥18 years of age.
The target lesion(s) must be located within the inner and middle two-thirds of the lung, as determined prospectively using the Software-Assisted Method (SAM). To ensure accurate localization, SAM applies anatomical measurements to classify lesions as inner, middle, or outer third of the lung. The lesion must contact the border of the inner two-thirds region; lesions fully outside this region will be excluded from the study cohort. In addition, the lesion must be located at least two airway generations distal to the main carina, as confirmed radiographically by the bronchoscopist
Target lesion: nodule ≥ 10mm or lymph node ≥ 5mm.
Concurrently participating in another competing clinical study.
Unwilling or unable to return for follow-up, e.g., plans for relocation, unsuitable transportation.
Patient not suitable for flexible bronchoscopy as determined by the treating physician prior to the procedure.
Currently on anticoagulation that cannot be paused, or a coagulation disorder that, in the opinion of the investigator, would pose an increased risk of bleeding.
Indicated for bronchoscopy
Other
Prospective
No Interventions
Other interventionno intervention, only observational
Ability to visualize and sample a priori defined lesion in the inner or middle third of the lung with BF-UCP190F.
The primary endpoint-the proportion of a priori defined inner/middle-third lesions visualized and sampled using the BF-UCP190F-will be summarized using descriptive statistics, including frequency and percentage with 95% confidence intervals.
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Olympus Europe SE & Co. KG
Lead sponsor
Heidelberg University
Collaborator
Lung Clinic Hemer
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
