A Clinical tRial of Endobronchial Ultrasound for the Diagnosis of MEDiastinal lymphadenopathY (REMEDY) (REMEDY)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|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)|
|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|
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.
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.
- 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 ]
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
|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|