Lung Cancer (Diagnosis)NCT07418450
Discrimination of N2a and N2b by EBUS-TBNA: is a Change of the Needle Necessary?
A study testing EBUS-TBNA in people with Lung Cancer (Diagnosis), run by University of Vienna at 1 site in Austria.
Trial summary
During EBUS staging in patients with mediastinal lymphadenopathy, it is planned to perform a first round of staging with change of the needle between all lymph nodes and a second round of staging without change of the needle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (Diagnosis)
- What is being tested?
- EBUS-TBNA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 5 Nov 2025to May 2027
- Phase
- Interventional
- 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
Who may be able to join
- Pulmonary lesion suspicious for lung cancer or histologically confirmed lung cancer
- indication for mediastinal staging
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna
Daniela Gompelmann, 0043 1 40400 47730, daniela.gompelmann@meduniwien.ac.at
About this study
Official title: Discrimination of N2a and N2b by EBUS-TBNA: is a Needle Change Necessary? - a Prospective Pilot Study
During EBUS staging in patients with mediastinal lymphadenopathy, it is planned to perform a first round of staging with change of the needle between all lymph nodes and a second round of staging without change of the needle.
- Conditions
- Lung Cancer (Diagnosis)
- Being tested
- EBUS-TBNA
- Medical subject headings
- Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBUS-TBNADiagnostic test
During EBUS staging, the needle well be changed between all lymph node stations in a first round. The EBUS staging will be repeated without the change of the needle between the lymph node stations.
| Study group | Role | What they receive |
|---|---|---|
| STudy group | Experimental | Not described Receives: Diagnostic Test: EBUS-TBNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between the two rounds of EBUS staging
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start5 Nov 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (Diagnosis)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Gompelmann, University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418450
- Sponsor's protocol ID
- 1.1 Needle change
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discrimination of N2a and N2b by EBUS-TBNA: is a Needle Change Necessary? - a Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT07418450
- Acronym / sponsor ID
- 1.1 Needle change
- Conditions
- Lung Cancer (Diagnosis)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ViennaUniversity, hospital or other
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 18 Feb 2026 (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.
During EBUS staging in patients with mediastinal lymphadenopathy, it is planned to perform a first round of staging with change of the needle between all lymph nodes and a second round of staging without change of the needle.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STudy group | Experimental | Diagnostic Test: EBUS-TBNA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pulmonary lesion suspicious for lung cancer or histologically confirmed lung cancer
- indication for mediastinal staging
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| EBUS-TBNADuring EBUS staging, the needle well be changed between all lymph node stations in a first round. The EBUS staging will be repeated without the change of the needle between the lymph node stations. | Diagnostic test | STudy group |
Primary outcome
Agreement between the two rounds of EBUS staging
Time frame: 18 months
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 18 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EBUS-TBNA in people with Lung Cancer (Diagnosis), run by University of Vienna at 1 site in Austria.
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 1 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: looking for participants now, as of the sponsor's last update on 18 Feb 2026. 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 Austria. 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?
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?
Contact Daniela Gompelmann (0043 1 40400 47730, daniela.gompelmann@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between the two rounds of EBUS staging (time frame: 18 months). 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 18 Feb 2026.