Peripheral Pulmonary LesionsNCT05512533
Feasibility of Thin Cp-EBUS Scope BF-UC290F for the Diagnosis of PPLs
A study testing Linear Ultrasound Bronchoscope BF-UC290F (Olympus) in people with Peripheral Pulmonary Lesions, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
The purpose of the study is to evaluate the diagnostic value and safety of Thin Convex Probe Endobronchial Ultrasound (TCP-EBUS) Scope for peripheral pulmonary lesions (PPLs) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Pulmonary Lesions
- What is being tested?
- Linear Ultrasound Bronchoscope BF-UC290F (Olympus)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 2 Sep 2022to 12 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Patients older than 18 years old.
- Chest imaging shows the presence of peripheral pulmonary lesions (surrounded by pulmonary parenchyma and located below the segmental bronchus as seen radiographically.) suspicious of malignancy, 0.8-5cm in greatest diameter in need of bronchoscopic biopsy for clinical purposes, and the investigators consider it possible to be biopsied with BF-UC290F (the bronchus adjacent or leading to the PPLs are close to 5mm in diameter, thus BF-UC290F is able to arrival/access).
- Patients without contraindications of bronchoscopy.
- Patients have good medical adherence and signed informed consent.
Who cannot join
- Peripheral pulmonary lesion is pure ground-glass opacity.
- Visible lumen lesions during bronchoscopy
- The lesions were adjacent to the central airway (trachea, left and right main bronchus, and right middle bronchus), and the biopsies by the Thin Convex Probe EBUS Scope BF-UC290F were conducted without leaf bronchus entry
- The investigators believe that patient has other conditions that are not suitable for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Safety of Thin Convex Probe EBUS Scope BF-UC290F for the Diagnosis of Peripheral Pulmonary Lesions
The purpose of the study is to evaluate the diagnostic value and safety of Thin Convex Probe Endobronchial Ultrasound (TCP-EBUS) Scope for peripheral pulmonary lesions (PPLs)
Read the detailed description
This study will determine the feasibility of the novel thin convex probe endobronchial ultrasound (TCP-EBUS) Scope for the diagnosis of peripheral pulmonary lesions. The primary end point is to clarify the feasibility of using the thin convex probe EBUS scope to biopsy peripheral pulmonary lesions. The secondary objective is to evaluate operation time, sample adequacy, factors affecting the diagnosis rate, etc. The safety, insertion ability, and operability of the thin convex probe EBUS would also be evaluated.
- Conditions
- Peripheral Pulmonary Lesions
- Being tested
- Linear Ultrasound Bronchoscope BF-UC290F (Olympus)
- Keywords
- EBUS-TBNA, diagnostic yield, peripheral pulmonary lesions (PPLs)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linear Ultrasound Bronchoscope BF-UC290F (Olympus)Device
A thin Olympus EBUS bronchoscope BF-UC290F will be used for all endobronchial ultrasound examinations, and biopsies will be conducted with EBUS needles - the ViziShot 2 22G (Olympus).
| Study group | Role | What they receive |
|---|---|---|
| BF-UC290F for diagnosing PPLs | Experimental | Thin EBUS endoscope is inserted and used to visualize peripheral pulmonary lesions, and biopsies will be conducted by EBUS-TBNA. Receives: Device: Linear Ultrasound Bronchoscope BF-UC290F (Olympus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield of BF-UC290F for PPLs
Diagnostic yield is defined as the proportion of peripheral pulmonary lesions (PPLs) diagnosed via endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in all lesions undergoing bronchoscopy biopsy via EBUS-TBNA.
Measured: Up to 6 months
Secondary outcomes (5)
EBUS scope operation time
It is defined as the total time from insertion of the EBUS scope to withdrawal of the EBUS scope
Measured: Immediately after each operation
The total time of lesion access
It is defined as the total time from the insertion of the EBUS scope to the arrival confirmed by ultrasound image.
Measured: Immediately after Each Operation
Factors affecting the diagnosis rate
Factors affecting the diagnosis rate, including the nature of the lesions, the size of the lesions, the location of the lesions and so on will be analyzed.
Measured: Up to 6 months
The bronchus level of lesions, and the bronchus level reached with the EBUS scope
Level: Main bronchus is level 0, lobar bronchus is level 1, segment bronchus is level 2, sub-segment bronchus is level 3, and so on, such as: LB3a is level 3
Measured: During the procedure
Specimen adequacy
The adequacy of specimens obtained by Thin Convex Probe EBUS Scope BF-UC290F for pathological typing, molecular testing, and immune checkpoint detection
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start2 Sep 2022
- Primary completion12 Feb 2023
- Study completion12 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Pulmonary LesionsStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiayuan Sun, Shanghai Chest Hospital
- Investigators
- Jiayuan Sun, MD., PhD., Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05512533
- Sponsor's protocol ID
- SHCHE202208
- Status last verified
- Jun 2025
- First submitted
- 21 Aug 2022
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhi X, Wang L, Chen J, Zheng X, Li Y, Sun J. Scoring model of convex probe endobronchial ultrasound multimodal imaging in differentiating benign and malignant lung lesions. J Thorac Dis. 2020 Dec;12(12):7645-7655. doi: 10.21037/jtd-2020-abpd-005.
PubMed 33447457Fujino K, Ujiie H, Kinoshita T, Lee CY, Igai H, Inage T, Motooka Y, Gregor A, Suzuki M, Yasufuku K. First Evaluation of the Next-Generation Endobronchial Ultrasound System in Preclinical Models. Ann Thorac Surg. 2019 May;107(5):1464-1471. doi: 10.1016/j.athoracsur.2018.11.068. Epub 2019 Jan 2.
PubMed 30610852
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Thin Convex Probe EBUS Scope BF-UC290F for the Diagnosis of Peripheral Pulmonary Lesions
- ClinicalTrials.gov ID
- NCT05512533
- Acronym / sponsor ID
- SHCHE202208
- Conditions
- Peripheral Pulmonary Lesions
- Keywords
- EBUS-TBNA, diagnostic yield, peripheral pulmonary lesions (PPLs)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 12 Feb 2023 (actual)
- Study completion
- 12 Jul 2023 (actual)
- First posted
- 23 Aug 2022 (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 purpose of the study is to evaluate the diagnostic value and safety of Thin Convex Probe Endobronchial Ultrasound (TCP-EBUS) Scope for peripheral pulmonary lesions (PPLs)
Detailed description
This study will determine the feasibility of the novel thin convex probe endobronchial ultrasound (TCP-EBUS) Scope for the diagnosis of peripheral pulmonary lesions. The primary end point is to clarify the feasibility of using the thin convex probe EBUS scope to biopsy peripheral pulmonary lesions. The secondary objective is to evaluate operation time, sample adequacy, factors affecting the diagnosis rate, etc. The safety, insertion ability, and operability of the thin convex probe EBUS would also be evaluated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BF-UC290F for diagnosing PPLs | Experimental | Device: Linear Ultrasound Bronchoscope BF-UC290F (Olympus)Thin EBUS endoscope is inserted and used to visualize peripheral pulmonary lesions, and biopsies will be conducted by EBUS-TBNA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients older than 18 years old.
- Chest imaging shows the presence of peripheral pulmonary lesions (surrounded by pulmonary parenchyma and located below the segmental bronchus as seen radiographically.) suspicious of malignancy, 0.8-5cm in greatest diameter in need of bronchoscopic biopsy for clinical purposes, and the investigators consider it possible to be biopsied with BF-UC290F (the bronchus adjacent or leading to the PPLs are close to 5mm in diameter, thus BF-UC290F is able to arrival/access).
- Patients without contraindications of bronchoscopy.
- Patients have good medical adherence and signed informed consent.
Key exclusion criteria (4 listed)
- Peripheral pulmonary lesion is pure ground-glass opacity.
- Visible lumen lesions during bronchoscopy
- The lesions were adjacent to the central airway (trachea, left and right main bronchus, and right middle bronchus), and the biopsies by the Thin Convex Probe EBUS Scope BF-UC290F were conducted without leaf bronchus entry
- The investigators believe that patient has other conditions that are not suitable for the study.
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 |
|---|---|---|
| Linear Ultrasound Bronchoscope BF-UC290F (Olympus)A thin Olympus EBUS bronchoscope BF-UC290F will be used for all endobronchial ultrasound examinations, and biopsies will be conducted with EBUS needles - the ViziShot 2 22G (Olympus). | Device | BF-UC290F for diagnosing PPLs |
Primary outcome
Diagnostic yield of BF-UC290F for PPLs
Time frame: Up to 6 months
Diagnostic yield is defined as the proportion of peripheral pulmonary lesions (PPLs) diagnosed via endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in all lesions undergoing bronchoscopy biopsy via EBUS-TBNA.
5 secondary outcomes
EBUS scope operation time
Time frame: Immediately after each operation
The total time of lesion access
Time frame: Immediately after Each Operation
Factors affecting the diagnosis rate
Time frame: Up to 6 months
The bronchus level of lesions, and the bronchus level reached with the EBUS scope
Time frame: During the procedure
Specimen adequacy
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Background: PubMed 33447457Zhi X, Wang L, Chen J, Zheng X, Li Y, Sun J. Scoring model of convex probe endobronchial ultrasound multimodal imaging in differentiating benign and malignant lung lesions. J Thorac Dis. 2020 Dec;12(12):7645-7655. doi: 10.21037/jtd-2020-abpd-005.
- Background: PubMed 30610852Fujino K, Ujiie H, Kinoshita T, Lee CY, Igai H, Inage T, Motooka Y, Gregor A, Suzuki M, Yasufuku K. First Evaluation of the Next-Generation Endobronchial Ultrasound System in Preclinical Models. Ann Thorac Surg. 2019 May;107(5):1464-1471. doi: 10.1016/j.athoracsur.2018.11.068. Epub 2019 Jan 2.
- 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. This study is not recruiting at the moment.
Jiayuan Sun, MD., PhD. principal investigator
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Linear Ultrasound Bronchoscope BF-UC290F (Olympus) in people with Peripheral Pulmonary Lesions, run by Shanghai Chest Hospital at 1 site in China.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diagnostic yield of BF-UC290F for PPLs (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05512533, which also lists 2 linked publications.
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 5 Jun 2025.