NCT07461662|Not Yet RecruitingFDA Device
Evaluation of Endobronchial Ultrasound Needle Cleaning Techniques and Their Impact on Specimen Contamination
EBUS
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EBUS
Sponsor study identifier
interventional
204
1 country
1
Study Start
April 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Endobronchial ultrasound (EBUS) bronchoscopy is commonly used to sample lymph nodes in patients with suspected or known lung cancer to determine the stage of the disease. Accurate staging is essential as it directly impacts treatment decisions and prognosis. During EBUS procedures, needles are often reused across multiple lymph node stations and are typically flushed with saline between samples. This raises the concern that residual tumor cells may contaminate the samples and could potentially incorrectly upstage disease. This prospective study will evaluate the current technique used during EBUS procedures to determine if more intensive cleaning leads to reduced cellular contamination without affecting diagnostics. Patients undergoing an EBUS procedure for diagnosis with a large mass and a high probability of malignancy will be selected for the study. Rapid On-Site Examination (ROSE) will be used at the bedside to determine the presence of abnormal cells. Following the final pass, before moving to the next station, the needle will be flushed with saline as normal and then flushed again into another container to evaluate the presence of residual cells. The outcome may help EBUS needle handling practices and improve lung cancer staging accuracy. No additional invasive procedures are performed as part of this study; all analyses utilize material obtained during routine EBUS needle flushing, with no added needle sticks or alteration of clinical care.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 16, 2026
Actual (reported)March 10, 2026
Actual (reported)April 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Cytologic Contamination
To determine the presence of cytologic contamination following standard practice cleaning techniques
From enrollment to the date of the pathological review report of the specimen taken during diagnostic EBUS sampling for a period of up to 32 weeks post enrollment and randomization in trial for each patient enrolled.
Incidence of Pathological Upstaging
From enrollment to the date of the pathological review report of the specimen taken during diagnostic EBUS sampling for a period of up to 32 weeks post enrollment and randomization in trial for each patient enrolled.
Effectiveness of Additional Flushing
From enrollment to the date of the pathological review report of the specimen taken during diagnostic EBUS sampling for a period of up to 32 weeks post enrollment and randomization in trial for each patient enrolled.
Additional flushing of the needle into a separate vial.
Standard saline flush following lesion sampling
Additional flushing of the needle into a separate vial
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Berim IG, Colanta A, Saeed AI, et al. Contamination of Needles Used for Endobronchial Ultrasound Guided Biopsies: Myth Confirmed. American Journal of Respiratory and Critical Care Medicine 2017;195:A2868
Tirapu Puyal JM, Mugica Atorrasagasti N, Leal Arranz MV, Santana Astudillo JC, Lopez Duque JC, Ortega Comunian L, Rezola Bajineta M, Segues Merino N. Cytologic Contamination of the Sampling Needle in Endobronchial Ultrasound. Arch Bronconeumol. 2022 Apr;58(4):367-368. doi: 10.1016/j.arbres.2021.07.011. Epub 2021 Aug 24. No abstract available. English, Spanish.
Yanglin Guo, MD
University of Mississippi Medical Center
First Submitted
February 16, 2026
First Posted
March 10, 2026
Study Start
A Phase 1 First-in-Human Study of CRPA1A2, a MAGE-A1/HLA-A*02:01 Bispecific T-Cell Engager, in Patients With Solid Tumors
Contact the study team to confirm eligibility.
April 1, 2026
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 10, 2026
Record last verified: 2026-03
Individual participant data, such as age and gender, that are utilized in results for publication will be shared.
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Source: ClinicalTrials.gov.
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