ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATIONROSENCT02028052
Procedural Outcomes in Endobronchial Ultrasound - Transbronchial Needle Aspiration (EBUS-TBNA) With and Without Rapid On-Site Evaluation (ROSE)
A study testing ROSE and 22 gauge Vizishot needles in people with ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION and Benign and Malignant Mediastinal and Hilar Lymph Nodes Known or Suspected Malignancy, run by Duke University at 1 site in United States.
Trial summary
The objective of this study is comparing the attributable procedural time of Endobronchial Ultrasound - Transbronchial Needle Aspiration (EBUS-TBNA) when sampling mediastinal and hilar lymph nodes with or without Rapid On-Site Evaluation (ROSE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION, Benign and Malignant Mediastinal and Hilar Lymph Nodes Known or Suspected Malignancy
- What is being tested?
- ROSE and 22 gauge Vizishot needles
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Nov 2014
- 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
- Subject provides informed consent
- Subject is >18 years of age
- Subject is scheduled to undergo flexible bronchoscopy with EBUS-TBNA of suspected enlarged mediastinal or hilar lymph nodes as part of their standard medical care
- A negative pregnancy test in women of child-bearing potential
- Subject is mentally capable of following study directions
Who cannot join
- Study subject has any disease or condition that interferes with safe completion of initial or follow-up assessments
- Concurrent participation in another study involving investigational drugs or investigational medical devices
- Inability to read and understand the necessary study documents
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Procedural Outcomes in Endobronchial Ultrasound - Transbronchial Needle Aspiration (EBUS-TBNA) With and Without Rapid On-Site Evaluation (ROSE) by Cytopathologist
The objective of this study is comparing the attributable procedural time of Endobronchial Ultrasound - Transbronchial Needle Aspiration (EBUS-TBNA) when sampling mediastinal and hilar lymph nodes with or without Rapid On-Site Evaluation (ROSE). The primary outcome will be the time elapsed from EBUS bronchoscope insertion to bronchoscope withdrawal. Secondary outcomes will include total number of sampled lymph nodes, average number of needle aspirations per lymph node sampled, overall diagnostic yield, and procedural time of the cytopathologist.
- Conditions
- ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION, Benign and Malignant Mediastinal and Hilar Lymph Nodes Known or Suspected Malignancy
- Being tested
- ROSE, 22 gauge Vizishot needles
- Keywords
- enlarged mediastinal nodes, enlarged hilar lymph nodes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROSEProcedure or surgery
The procedure will proceed with conventional EBUS-TBNA sampling of the target lesion with 22 gauge Vizishot needles. Each subject will be randomized to either ROSE by cytopathologist or no ROSE.
22 gauge Vizishot needlesDevice
| Study group | Role | What they receive |
|---|---|---|
| ROSE | Other | In the case of ROSE, sampling frequency will occur similarly, but no additional samples will be taken in the case of provision of a preliminary diagnosis. Receives: Procedure: ROSE; Device: 22 gauge Vizishot needles |
| NO ROSE | Other | In the case of no ROSE, sampling frequency will be predetermined at 4 needle aspirations per site Receives: Procedure: ROSE; Device: 22 gauge Vizishot needles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time lapse
The primary endpoint is the time elapsed from EBUS bronchoscope insertion to bronchoscope withdrawal.
Measured: during procedure, approximately 45 minutes
Secondary outcomes (4)
Total number of sampled lymph nodes
Samples taken during procedure
Measured: approximately 45 minutes
Average number of needle aspirations per lymph node sampled
Determined by tumor
Measured: approximately 45 minutes
Overall diagnostic yield
Measured: approximately 45 minutes
Procedural time of the cytopathologist
Measured: approximately 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startApr 2012
- Primary completionNov 2014
- Study completionNov 2014
Why it stopped: similar study data published
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATIONStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Momen Wahidi, MD, MBA, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028052
- Sponsor's protocol ID
- Pro00036432
- Acronym
- ROSE
- Status last verified
- Jan 2015
- First submitted
- 20 Dec 2013
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yasufuku K, Chiyo M, Sekine Y, Chhajed PN, Shibuya K, Iizasa T, Fujisawa T. Real-time endobronchial ultrasound-guided transbronchial needle aspiration of mediastinal and hilar lymph nodes. Chest. 2004 Jul;126(1):122-8. doi: 10.1378/chest.126.1.122.
PubMed 15249452Mejia CP. [Surgery and orthodontics in the treatment of unerupted maxillary cuspids]. Rev Fed Odontol Colomb. 1976 Jan-Jun;24(116-117):47-52. No abstract available. Spanish.
PubMed 1076725Griffin AC, Schwartz LE, Baloch ZW. Utility of on-site evaluation of endobronchial ultrasound-guided transbronchial needle aspiration specimens. Cytojournal. 2011;8:20. doi: 10.4103/1742-6413.90081. Epub 2011 Nov 21.
PubMed 22145008Layfield LJ, Bentz JS, Gopez EV. Immediate on-site interpretation of fine-needle aspiration smears: a cost and compensation analysis. Cancer. 2001 Oct 25;93(5):319-22. doi: 10.1002/cncr.9046.
PubMed 11668466
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procedural Outcomes in Endobronchial Ultrasound - Transbronchial Needle Aspiration (EBUS-TBNA) With and Without Rapid On-Site Evaluation (ROSE) by Cytopathologist
- ClinicalTrials.gov ID
- NCT02028052
- Acronym / sponsor ID
- ROSE / Pro00036432
- Conditions
- ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION, Benign and Malignant Mediastinal and Hilar Lymph Nodes Known or Suspected Malignancy
- Keywords
- enlarged mediastinal nodes, enlarged hilar lymph nodes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: similar study data published
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 6 Jan 2014 (estimated)
- 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 objective of this study is comparing the attributable procedural time of Endobronchial Ultrasound - Transbronchial Needle Aspiration (EBUS-TBNA) when sampling mediastinal and hilar lymph nodes with or without Rapid On-Site Evaluation (ROSE). The primary outcome will be the time elapsed from EBUS bronchoscope insertion to bronchoscope withdrawal. Secondary outcomes will include total number of sampled lymph nodes, average number of needle aspirations per lymph node sampled, overall diagnostic yield, and procedural time of the cytopathologist.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ROSE | Other | Procedure: ROSE, Device: 22 gauge Vizishot needlesIn the case of ROSE, sampling frequency will occur similarly, but no additional samples will be taken in the case of provision of a preliminary diagnosis. |
| NO ROSE | Other | Procedure: ROSE, Device: 22 gauge Vizishot needlesIn the case of no ROSE, sampling frequency will be predetermined at 4 needle aspirations per site |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject provides informed consent
- Subject is >18 years of age
- Subject is scheduled to undergo flexible bronchoscopy with EBUS-TBNA of suspected enlarged mediastinal or hilar lymph nodes as part of their standard medical care
- A negative pregnancy test in women of child-bearing potential
- Subject is mentally capable of following study directions
Key exclusion criteria (3 listed)
- Study subject has any disease or condition that interferes with safe completion of initial or follow-up assessments
- Concurrent participation in another study involving investigational drugs or investigational medical devices
- Inability to read and understand the necessary study documents
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 |
|---|---|---|
| ROSEThe procedure will proceed with conventional EBUS-TBNA sampling of the target lesion with 22 gauge Vizishot needles. Each subject will be randomized to either ROSE by cytopathologist or no ROSE. | Procedure or surgery | NO ROSE, ROSE |
| 22 gauge Vizishot needles | Device | NO ROSE, ROSE |
Primary outcome
Time lapse
Time frame: during procedure, approximately 45 minutes
The primary endpoint is the time elapsed from EBUS bronchoscope insertion to bronchoscope withdrawal.
4 secondary outcomes
Total number of sampled lymph nodes
Time frame: approximately 45 minutes
Average number of needle aspirations per lymph node sampled
Time frame: approximately 45 minutes
Overall diagnostic yield
Time frame: approximately 45 minutes
Procedural time of the cytopathologist
Time frame: approximately 30 minutes
Results and safety
The study was stopped early (reason given: similar study data published). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- Background: PubMed 15249452Yasufuku K, Chiyo M, Sekine Y, Chhajed PN, Shibuya K, Iizasa T, Fujisawa T. Real-time endobronchial ultrasound-guided transbronchial needle aspiration of mediastinal and hilar lymph nodes. Chest. 2004 Jul;126(1):122-8. doi: 10.1378/chest.126.1.122.
- Background: PubMed 1076725Mejia CP. [Surgery and orthodontics in the treatment of unerupted maxillary cuspids]. Rev Fed Odontol Colomb. 1976 Jan-Jun;24(116-117):47-52. No abstract available. Spanish.
- Background: PubMed 22145008Griffin AC, Schwartz LE, Baloch ZW. Utility of on-site evaluation of endobronchial ultrasound-guided transbronchial needle aspiration specimens. Cytojournal. 2011;8:20. doi: 10.4103/1742-6413.90081. Epub 2011 Nov 21.
- Background: PubMed 11668466Layfield LJ, Bentz JS, Gopez EV. Immediate on-site interpretation of fine-needle aspiration smears: a cost and compensation analysis. Cancer. 2001 Oct 25;93(5):319-22. doi: 10.1002/cncr.9046.
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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.
Momen Wahidi, MD, MBA principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ROSE and 22 gauge Vizishot needles in people with ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION and Benign and Malignant Mediastinal and Hilar Lymph Nodes Known or Suspected Malignancy, run by Duke University 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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 15 Feb 2017. 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 was stopped early (reason given: similar study data published). Results are not available in the source record.
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?
Time lapse (time frame: during procedure, approximately 45 minutes). 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 NCT02028052, which also lists 4 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 15 Feb 2017.