Mediastinal and Hilar LymphadenopathySPEED NEEDLENCT07218042
Study of Procedural Efficiency in EBUS With Dual Versus Single NEEDLEs: Evaluating the Value of a Second Needle in EBUS as it Pertains to Economic and Environmental Impact
A study testing We randomized patients to the two arms above; there was no specific intervention performed other than randomizing patients to one or two needles. in people with Mediastinal and Hilar Lymphadenopathy, run by Christopher Kapp at 3 sites in United States.
Trial summary
Currently, the EBUS bronchoscopy procedure uses either one or two needles to perform the biopsy of the lymph node based on physician preference. We want to determine the optimal number of needles to use for future EBUS bronchoscopy procedures like the one you are scheduled to have for your care and investigate the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mediastinal and Hilar Lymphadenopathy
- What is being tested?
- We randomized patients to the two arms above; there was no specific intervention performed other than randomizing patients to one or two needles.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Feb 2024to 31 Dec 2025
- 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
- Undergoing a bronchoscopy with lymph node sampling
Who cannot join
- Unable to get a bronchoscopy procedure for various reasons
- Other criteria per protocol uploaded
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Northwestern University
Chicago, Illinois, 60611
Duke University
Durham, North Carolina, 27710
University of California, Davis
Sacramento, California, 95817
About this study
Official title: Are Two Needles Really Better Than One? A Time, Economic, and Environmental Evaluation of EBUS-TBNA
Currently, the EBUS bronchoscopy procedure uses either one or two needles to perform the biopsy of the lymph node based on physician preference. We want to determine the optimal number of needles to use for future EBUS bronchoscopy procedures like the one you are scheduled to have for your care and investigate the economic and environmental impact and time involved in using one versus two needles.
Read the detailed description
Endobronchial Ultrasound (EBUS) is a mainstay of diagnostic bronchoscopy, as it is performed for mediastinal and hilar lymph node sampling for cancer staging, diagnosis of sarcoidosis, lymphoma, infection, and other disease processes. It is a procedure that is commonplace in all bronchoscopy suites across the world.
In our bronchoscopy suite, our current practice varies based on the bronchoscopist and number of lymph nodes requiring sampling in a procedure (can range from 1-5) as to whether one or two needles are utilized. The bronchoscopist may use two needles to save time when multiple lymph nodes must be biopsied or if an individual node needs to be biopsied several times to obtain more tissue for pathologic study.
EBUS needles are single use and there is one randomized trial (n=20 patients) that showed a decreased time of procedure in patients where two needles were used versus one (Khan et al., 2013). However, no data exist evaluating the economic impact (cost of needle versus endoscopy dollars saved) or environmental impact of using one versus two needles. This study will examine these factors to determine the optimal way to perform this procedure in the future, considering the procedure and anesthesia time, economic costs, and environmental costs.
- Conditions
- Mediastinal and Hilar Lymphadenopathy
- Being tested
- We randomized patients to the two arms above; there was no specific intervention performed other than randomizing patients to one or two needles.
- Keywords
- Bronchoscopy, EBUS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
We randomized patients to the two arms above; there was no specific intervention performed other than randomizing patients to one or two needles.Diagnostic test
We randomized patients to the two arms above; there was no specific intervention performed other than randomizing patients to one or two needles.
| Study group | Role | What they receive |
|---|---|---|
| One EBUS Needle | Active comparator | Patients underwent a standard of care EBUS with one needle utilized in the procedure. Receives: Diagnostic Test: We randomized patients to the two arms above; there was no specific intervention performed other than randomizing patients to one or two needles. |
| Two EBUS Needle | Experimental | Patients underwent standard of care EBUS with two needles used. Receives: Diagnostic Test: We randomized patients to the two arms above; there was no specific intervention performed other than randomizing patients to one or two needles. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Under Anesthesia
Measured: During bronchoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start2 Feb 2024
- Primary completion1 Aug 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mediastinal and Hilar LymphadenopathyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher Kapp
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, University of California, Davis
- Responsible party
- Sponsor-investigator, Christopher Kapp, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218042
- Sponsor's protocol ID
- STU00220729
- Acronym
- SPEED NEEDLE
- Status last verified
- Oct 2025
- First submitted
- 15 Oct 2025
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Two Needles Really Better Than One? A Time, Economic, and Environmental Evaluation of EBUS-TBNA
- ClinicalTrials.gov ID
- NCT07218042
- Acronym / sponsor ID
- SPEED NEEDLE / STU00220729
- Conditions
- Mediastinal and Hilar Lymphadenopathy
- Keywords
- Bronchoscopy, EBUS
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Christopher KappUniversity, hospital or other
- Collaborators
- Duke University, University of California, Davis
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Oct 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.
Currently, the EBUS bronchoscopy procedure uses either one or two needles to perform the biopsy of the lymph node based on physician preference. We want to determine the optimal number of needles to use for future EBUS bronchoscopy procedures like the one you are scheduled to have for your care and investigate the economic and environmental impact and time involved in using one versus two needles.
Detailed description
Endobronchial Ultrasound (EBUS) is a mainstay of diagnostic bronchoscopy, as it is performed for mediastinal and hilar lymph node sampling for cancer staging, diagnosis of sarcoidosis, lymphoma, infection, and other disease processes. It is a procedure that is commonplace in all bronchoscopy suites across the world.
In our bronchoscopy suite, our current practice varies based on the bronchoscopist and number of lymph nodes requiring sampling in a procedure (can range from 1-5) as to whether one or two needles are utilized. The bronchoscopist may use two needles to save time when multiple lymph nodes must be biopsied or if an individual node needs to be biopsied several times to obtain more tissue for pathologic study.
EBUS needles are single use and there is one randomized trial (n=20 patients) that showed a decreased time of procedure in patients where two needles were used versus one (Khan et al., 2013). However, no data exist evaluating the economic impact (cost of needle versus endoscopy dollars saved) or environmental impact of using one versus two needles. This study will examine these factors to determine the optimal way to perform this procedure in the future, considering the procedure and anesthesia time, economic costs, and environmental costs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One EBUS Needle | Active comparator | Diagnostic Test: We randomized patients to the two arms above; there was no specific intervention performed other than randomizing patients to one or two needles.Patients underwent a standard of care EBUS with one needle utilized in the procedure. |
| Two EBUS Needle | Experimental | Diagnostic Test: We randomized patients to the two arms above; there was no specific intervention performed other than randomizing patients to one or two needles.Patients underwent standard of care EBUS with two needles used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing a bronchoscopy with lymph node sampling
Key exclusion criteria (2 listed)
- Unable to get a bronchoscopy procedure for various reasons
- Other criteria per protocol uploaded
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 |
|---|---|---|
| We randomized patients to the two arms above; there was no specific intervention performed other than randomizing patients to one or two needles.We randomized patients to the two arms above; there was no specific intervention performed other than randomizing patients to one or two needles. | Diagnostic test | One EBUS Needle, Two EBUS Needle |
Primary outcome
Time Under Anesthesia
Time frame: During bronchoscopy procedure
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 20 Oct 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing We randomized patients to the two arms above; there was no specific intervention performed other than randomizing patients to one or two needles. in people with Mediastinal and Hilar Lymphadenopathy, run by Christopher Kapp at 3 sites 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 1 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: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
Time Under Anesthesia (time frame: During bronchoscopy 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 20 Oct 2025.