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

NCT07253727 | Not Yet Recruiting

• 1 other identifier: 2025-02
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Bronchoscopy

Outcome Measures

Primary Outcomes (1)

• 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.

  Index Procedure

Study Arms (1)

Indicated for bronchoscopy

Other: No Interventions

Interventions

No Interventions OTHER

no intervention, only observational

Indicated for bronchoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Indicated for bronchoscopy

You may qualify if:

• 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.
• Target lesion location documented on CT or PET report.
• Indicated for bronchoscopy.
• Bronchoscopic procedure scheduled within 30 days of the CT or PET report.
• Patient qualifies for a procedure using the BF-UCP190F bronchoscope and the ViziShot 2 25 needle based upon the approved indications for use for those devices.

You may not qualify if:

• 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.
• Intraprocedural identification of intrinsic and endoscopically visualized endobronchial lesion for which adequate biopsy can be obtained via endobronchial biopsy.

Sponsors & Collaborators

• Olympus Europe SE & Co. KG: lead
• Heidelberg University: collaborator
• Lung Clinic Hemer: collaborator

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 28, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share