Peripheral Pulmonary NodulesNCT04331587
Thin and Ultrathin Bronchoscopy With Transbronchial Needle Aspiration and Radial Probe Endobronchial Ultrasound for Peripheral Pulmonary Lesions
An observational study of Peripheral Pulmonary Nodules, run by Washington University School of Medicine at 1 site in United States.
Trial summary
To collect data on diagnostic yield of thin and ultrathin bronchoscopes with radial probe endobronchial ultrasound (radial EBUS) and transbronchial needle aspiration (TBNA) during routine standard of care bronchoscopy for peripheral pulmonary lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Pulmonary Nodules
- What is being tested?
- BF-P190 4 mm thin bronchoscope, BF-MP190F 3 mm ultrathin bronchoscope and Radial ultrasound probe (UM S20-17S)
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2020to 22 Aug 2024
- Phase
- Observational
- 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
Study population: Patients being seen at Washington University School of Medicine.
Who may be able to join
- Patients age 18 and older
- Patients presenting with peripheral pulmonary lesions 1-7cm in greatest diameter on axial CT or PET scan in need of bronchoscopic biopsy for clinical purposes
Who cannot join
- Patients who are unable to undergo flexible bronchoscopy as determined by the bronchoscopist prior to the procedure
- Patients unwilling or unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Evaluation of Thin and Ultrathin Bronchoscopy With Transbronchial Needle Aspiration and Radial Probe Endobronchial Ultrasound for Peripheral Pulmonary Lesions
To collect data on diagnostic yield of thin and ultrathin bronchoscopes with radial probe endobronchial ultrasound (radial EBUS) and transbronchial needle aspiration (TBNA) during routine standard of care bronchoscopy for peripheral pulmonary lesions.
- Conditions
- Peripheral Pulmonary Nodules
- Being tested
- BF-P190 4 mm thin bronchoscope, BF-MP190F 3 mm ultrathin bronchoscope, Radial ultrasound probe (UM S20-17S), PeriView FLEX 21G Single Use Aspiration Needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BF-P190 4 mm thin bronchoscopeDevice
- EVIS EXERA III Bronchofiberviedoscopes
- Olympus
BF-MP190F 3 mm ultrathin bronchoscopeDevice
- EVIS EXERA III Bronchofiberviedoscopes
- Olympus
Radial ultrasound probe (UM S20-17S)Device
-Olympus
PeriView FLEX 21G Single Use Aspiration NeedleDevice
- NA-403D-2021
- Gyrus ACMI, Inc.
| Study group | Role | What they receive |
|---|---|---|
| Bronchoscopy | The bronchoscopy procedure and use of both the thin and ultrathin bronchoscopes are considered standard of care and will be performed under moderate sedation in an outpatient bronchoscopy suite as part of each patient's clinical care. Receives: Device: BF-P190 4 mm thin bronchoscope; Device: BF-MP190F 3 mm ultrathin bronchoscope; Device: Radial ultrasound probe (UM S20-17S); Device: PeriView FLEX 21G Single Use Aspiration Needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall diagnostic yield (concentric and eccentric lesions) for peripheral pulmonary nodules
-To determine overall diagnostic yield (concentric and eccentric lesions) for peripheral pulmonary nodules utilizing using a standard of care combined approach of 4mm thin and 3mm ultrathin bronchoscopes with TBNA and radial EBUS and compare it to a historical baseline diagnostic yield of 60% established at Washington University School of Medicine (WUSM) when using TBNA and radial EBUS and a 4mm thin bronchoscope.
Measured: Receipt of cytology/histopathology results (approximately 7 days)
Secondary outcomes (6)
Incidence of related adverse events
-Adverse events related to the bronchoscopy procedure and/or devices used during the procedure (bronchoscope, radial EBUS, PeriView Flex needle).
Measured: Up to 4 days following procedure
Procedure time measured in minutes from oral scope insertion to scope removal upon completion of the bronchoscopy procedure
Measured: From start of procedure through end of procedure (day 1)
Size of target lesions measured at the greatest diameter in centimeters
Measured: From start of procedure through end of procedure (day 1)
Diagnostic yield of bronchoscopy utilizing a 3mm bronchoscope for eccentric lesions
-Will be compared with historical controlled data of cases in which peripheral bronchoscopy was performed for peripheral lesions using radial probe EBUS and a 4mm bronchoscope in which eccentric ultrasound views were obtained
Measured: Receipt of cytology/histopathology results (approximately 7 days)
Ability to successfully convert ultrasound images from eccentric to concentric view by exchanging the 4mm thin bronchoscope for the 3mm ultrathin bronchoscope
-The ability to convert will be based on the ultrasound image that is obtained using the 3mm bronchoscope (it will either be eccentric or concentric) compared to the eccentric ultrasound image obtained with the 4mm bronchoscope
Measured: From start of procedure through end of procedure (day 1)
Types of deficiencies associated with medical device
Measured: From start of procedure through end of procedure (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start20 Apr 2020
- Primary completion22 Aug 2024
- Study completion22 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Pulmonary NodulesStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Olympus
- Responsible party
- Sponsor
- Investigators
- Alexander Chen, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331587
- Sponsor's protocol ID
- 202003071
- Status last verified
- Sep 2024
- First submitted
- 27 Mar 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Thin and Ultrathin Bronchoscopy With Transbronchial Needle Aspiration and Radial Probe Endobronchial Ultrasound for Peripheral Pulmonary Lesions
- ClinicalTrials.gov ID
- NCT04331587
- Acronym / sponsor ID
- 202003071
- Conditions
- Peripheral Pulmonary Nodules
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Olympus
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 22 Aug 2024 (actual)
- Study completion
- 22 Aug 2024 (actual)
- First posted
- 2 Apr 2020 (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.
To collect data on diagnostic yield of thin and ultrathin bronchoscopes with radial probe endobronchial ultrasound (radial EBUS) and transbronchial needle aspiration (TBNA) during routine standard of care bronchoscopy for peripheral pulmonary lesions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bronchoscopy | – | Device: BF-P190 4 mm thin bronchoscope, Device: BF-MP190F 3 mm ultrathin bronchoscope, Device: Radial ultrasound probe (UM S20-17S), Device: PeriView FLEX 21G Single Use Aspiration NeedleThe bronchoscopy procedure and use of both the thin and ultrathin bronchoscopes are considered standard of care and will be performed under moderate sedation in an outpatient bronchoscopy suite as part of each patient's clinical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients being seen at Washington University School of Medicine.
Key inclusion criteria (2 listed)
- Patients age 18 and older
- Patients presenting with peripheral pulmonary lesions 1-7cm in greatest diameter on axial CT or PET scan in need of bronchoscopic biopsy for clinical purposes
Key exclusion criteria (2 listed)
- Patients who are unable to undergo flexible bronchoscopy as determined by the bronchoscopist prior to the procedure
- Patients unwilling or unable to provide informed consent.
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 |
|---|---|---|
| BF-P190 4 mm thin bronchoscope* EVIS EXERA III Bronchofiberviedoscopes * Olympus | Device | Bronchoscopy |
| BF-MP190F 3 mm ultrathin bronchoscope* EVIS EXERA III Bronchofiberviedoscopes * Olympus | Device | Bronchoscopy |
| Radial ultrasound probe (UM S20-17S)-Olympus | Device | Bronchoscopy |
| PeriView FLEX 21G Single Use Aspiration Needle* NA-403D-2021 * Gyrus ACMI, Inc. | Device | Bronchoscopy |
Primary outcome
Overall diagnostic yield (concentric and eccentric lesions) for peripheral pulmonary nodules
Time frame: Receipt of cytology/histopathology results (approximately 7 days)
-To determine overall diagnostic yield (concentric and eccentric lesions) for peripheral pulmonary nodules utilizing using a standard of care combined approach of 4mm thin and 3mm ultrathin bronchoscopes with TBNA and radial EBUS and compare it to a historical baseline diagnostic yield of 60% established at Washington University School of Medicine (WUSM) when using TBNA and radial EBUS and a 4mm thin bronchoscope.
6 secondary outcomes
Incidence of related adverse events
Time frame: Up to 4 days following procedure
Procedure time measured in minutes from oral scope insertion to scope removal upon completion of the bronchoscopy procedure
Time frame: From start of procedure through end of procedure (day 1)
Size of target lesions measured at the greatest diameter in centimeters
Time frame: From start of procedure through end of procedure (day 1)
Diagnostic yield of bronchoscopy utilizing a 3mm bronchoscope for eccentric lesions
Time frame: Receipt of cytology/histopathology results (approximately 7 days)
Ability to successfully convert ultrasound images from eccentric to concentric view by exchanging the 4mm thin bronchoscope for the 3mm ultrathin bronchoscope
Time frame: From start of procedure through end of procedure (day 1)
Types of deficiencies associated with medical device
Time frame: From start of procedure through end of procedure (day 1)
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 19 Sep 2024.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- 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.
Alexander Chen, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Pulmonary Nodules, run by Washington University School of Medicine at 1 site in United States.
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 2 inclusion and 2 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 19 Sep 2024. 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 United States. 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?
Overall diagnostic yield (concentric and eccentric lesions) for peripheral pulmonary nodules (time frame: Receipt of cytology/histopathology results (approximately 7 days)). 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 19 Sep 2024.