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EBUS-TBNA vs Acquire TBNB

NCT04200105 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2019-12-18

No results posted yet for this study

Summary

This study aims to determine whether a new type of needle used for sampling lymph nodes (glands) around the airways of the lung, during a procedure called an endobronchial ultrasound (EBUS, provides more or better quality tissue to allow a definite diagnosis to be made than with the current standard sampling needle. Two hundred and fifty patients will be randomised to procedures using either the new or standard needle, and the results compared.

Conditions

  • Mediastinal Lymphadenopathy

Interventions

DEVICE

EBUS-TBNA

Mediastinal and hilar lymph node sampling using a standard 22G EBUS needle

DEVICE

Acquire TBNB

Mediastinal and hilar lymph node sampling using the Acquire TBNB needle

Sponsors & Collaborators

  • Royal Brompton & Harefield NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Samuel V Kemp, MBBS · Royal Brompton and Harefield NHS FT

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-02
Primary Completion
2021-03-01
Completion
2021-08-01
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04200105 on ClinicalTrials.gov