A Clinical tRial of Endobronchial Ultrasound for the Diagnosis of MEDiastinal lymphadenopathY (REMEDY) (REMEDY)
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ClinicalTrials.gov Identifier: NCT00932854 |
Recruitment Status
: Unknown
Verified October 2011 by Sam Janes, University College London Hospitals.
Recruitment status was: Active, not recruiting
First Posted
: July 3, 2009
Last Update Posted
: October 18, 2011
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Condition or disease | Intervention/treatment | Phase |
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Isolated Mediastinal Lymphadenopathy Sarcoidosis Tuberculosis Lung Cancer Lymphoma | Procedure: EBUS | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 75 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | A Clinical tRial of Endobronchial Ultrasound for the Diagnosis of Isolated MEDiastinal lymphadenopathY (REMEDY) |
Study Start Date : | July 2009 |
Actual Primary Completion Date : | April 2011 |
Estimated Study Completion Date : | October 2011 |

Arm | Intervention/treatment |
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Experimental: EBUS
All patients in the trial will undergo EBUS for the diagnosis of isolated mediastinal lymphadenopathy. If this investigation is negative then the patient will be referred for mediastinoscopy.
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Procedure: EBUS
Endobronchial ultrasound guided transbronchial needle aspiration will be performed under conscious sedation and as an outpatient procedure. Additional bronchoscopy, transbronchial biopsies and bronchoalveolar lavage will be performed at the investigator's discretion.
Other Names:
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- Number of mediastinoscopies prevented and healthcare costs [ Time Frame: At diagnosis ]
- Length of hospital stay [ Time Frame: At diagnosis ]
- Sensitivity and false negative rate of endobronchial ultrasound [ Time Frame: At study completion ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Consecutive patients with undiagnosed mediastinal lymphadenopathy (>1cm in short axis) on CT or PET-CT scan for whom pathological evaluation is clinically indicated.
Exclusion Criteria:
- Patients without informed consent, those with anterior mediastinal lesions or with contra-indications to EBUS or mediastinoscopy will be excluded.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00932854
United Kingdom | |
University College London Hospital | |
London, United Kingdom, WC1E 5DB |
Principal Investigator: | Sam Janes, MD PhD | University College, London | |
Study Director: | Neal Navani, MD | Univeristy College London |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sam Janes, Reader in Respiratory Medicine, University College London Hospitals |
ClinicalTrials.gov Identifier: | NCT00932854 History of Changes |
Other Study ID Numbers: |
REMEDY 09/0090 |
First Posted: | July 3, 2009 Key Record Dates |
Last Update Posted: | October 18, 2011 |
Last Verified: | October 2011 |
Keywords provided by Sam Janes, University College London Hospitals:
Mediastinal lymphadenopathy EBUS Bronchoscopy Sarcoidosis |
Additional relevant MeSH terms:
Tuberculosis Sarcoidosis Lymphadenopathy Mycobacterium Infections Actinomycetales Infections |
Gram-Positive Bacterial Infections Bacterial Infections Lymphoproliferative Disorders Lymphatic Diseases |