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Not yet recruitingNCT07253727LUCENTUpdated Nov 28, 2025

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

An observational study in Bronchoscopy, sponsored by Olympus Europe SE & Co. KG. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-28.

Sponsored by Olympus Europe SE & Co. KG · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Bronchoscopy
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In context

Lead sponsor

Olympus Europe SE & Co. KG is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Indicated for bronchoscopy

Inclusion criteria

  1. Willing and able to provide informed consent.
  2. ≥18 years of age.
  3. 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
  4. Target lesion: nodule ≥ 10mm or lymph node ≥ 5mm.
  5. Target lesion location documented on CT or PET report.
  6. Indicated for bronchoscopy.
  7. Bronchoscopic procedure scheduled within 30 days of the CT or PET report.
  8. 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.

Exclusion criteria

Exclusion Criteria:

  1. Concurrently participating in another competing clinical study.
  2. Unwilling or unable to return for follow-up, e.g., plans for relocation, unsuitable transportation.
  3. Patient not suitable for flexible bronchoscopy as determined by the treating physician prior to the procedure.
  4. 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.
  5. Intraprocedural identification of intrinsic and endoscopically visualized endobronchial lesion for which adequate biopsy can be obtained via endobronchial biopsy.
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Indicated for bronchoscopy

    Other: No Interventions

Interventions

  • OtherNo Interventions

    no intervention, only observational

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What researchers measure

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.

    Time frame: Index Procedure

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07253727
Lead sponsor
Olympus Europe SE & Co. KG
Collaborators
Heidelberg University, Lung Clinic Hemer
Responsible party
Sponsor
First posted
Nov 28, 2025
Start date
Dec 1, 2025 (estimated)
Primary completion
Jan 31, 2027 (estimated)
Completion
Aug 31, 2028 (estimated)
Last update
Nov 28, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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