BronchoscopyLUCENTNCT07253727
The LUCENT Study - LUng Lesion Assessment Via BF-UCP190F for Central and Extended Nodal Targeting
An observational study of Bronchoscopy, run by Olympus Europe SE & Co. KG.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchoscopy
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 31 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Indicated for bronchoscopy
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
- Being tested
- No Interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
no intervention, only observational
| Study group | Role | What they receive |
|---|---|---|
| Indicated for bronchoscopy | Not described Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Index Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olympus Europe SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Heidelberg University, Lung Clinic Hemer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253727
- Sponsor's protocol ID
- 2025-02
- Acronym
- LUCENT
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The LUCENT Study - LUng Lesion Assessment Via BF-UCP190F for Central and Extended Nodal Targeting
- ClinicalTrials.gov ID
- NCT07253727
- Acronym / sponsor ID
- LUCENT / 2025-02
- Conditions
- Bronchoscopy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Olympus Europe SE & Co. KGIndustry (pharma, biotech, devices)
- Collaborators
- Heidelberg University, Lung Clinic Hemer
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indicated for bronchoscopy | – | Other: No Interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Indicated for bronchoscopy
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Interventionsno intervention, only observational | Other | Indicated for bronchoscopy |
Primary outcome
Ability to visualize and sample a priori defined lesion in the inner or middle third of the lung with BF-UCP190F.
Time frame: Index Procedure
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchoscopy, run by Olympus Europe SE & Co. KG.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to visualize and sample a priori defined lesion in the inner or middle third of the lung with BF-UCP190F. (time frame: Index Procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.