The LUCENT Study - LUng Lesion Assessment Via BF-UCP190F for Central and Extended Nodal Targeting

ConditionBronchoscopy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOlympus Europe SE & Co. KG

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • No Interventions

Treatment groups

200 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Olympus Europe SE & Co. KG

Lead sponsor

Heidelberg University

Collaborator

Lung Clinic Hemer

Collaborator