Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Transbronchial Needle Forceps for Endobronchial Ultrasound

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: NCT01145924
Recruitment Status : Unknown
Verified February 2010 by Heidelberg University.
Recruitment status was:  Recruiting
First Posted : June 17, 2010
Last Update Posted : June 17, 2010
Sponsor:
Information provided by:
Heidelberg University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Prove the feasibility of a needle forceps in patients with enlarged mediastinal lymph nodes

Condition or disease Intervention/treatment Phase
Lung Cancer Lymph Nodes Procedure: EBUS TBNF Phase 2

Detailed Description:
Patients with enlarged mediastinal lymph nodes must be staged. The EBUS TBNA technique is an established technique. Unfortunately the size of the needle is limited to 21 gauge. With tne new designed needle forceps it should be possible to obtain more material and establish the diagnosis more often
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Transbronchial Needle Forceps for EBUS
Study Start Date : January 2010
Estimated Primary Completion Date : August 2010
Estimated Study Completion Date : August 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: EBUS TBNF
single arm trial, patients with enlarged mediastinal nodes will be examine
 Procedure: EBUS TBNF
Transbronchial needle forceps will be use with the EBUS TBNA scope
Other Name: Endobronchial ultrasound


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of Participants with a positive biopsy result [ Time Frame: 2 days after intervention ]

Secondary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 weeks after ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • enlarged mediastinal lymph nodes

Exclusion Criteria:

  • comorbidities
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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): NCT01145924


Contacts
Layout table for location contacts
Contact: Felix JF Herth, PhD, MD +49 6221 396 ext 1200 Felix.Herth@thoraxklinik-heidelberg.de

Locations
Layout table for location information
Germany
Thoraxklinik Recruiting
Heidelberg, Germany, 69126
Contact: Ralf Eberhardt, MD    +49 6221 396 ext 8204    Ralf.Eberhardt@thoraxklinik-heidelberg.de   
Sub-Investigator: Ralf Eberhardt, MD         
Principal Investigator: Felix JF Herth, PhD, MD         
Sponsors and Collaborators
Heidelberg University
Investigators
Layout table for investigator information
Study Director: Hendrik Dienemann, PhD, MD Heidelberg University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Prof. Felix JF Herth, Thoraxklinik Heidelberg
ClinicalTrials.gov Identifier: NCT01145924    
Other Study ID Numbers: HD 08
First Posted: June 17, 2010    Key Record Dates
Last Update Posted: June 17, 2010
Last Verified: February 2010
Keywords provided by Heidelberg University:
bronchoscopy
endobronchial ultrasound
transbronchial needle aspiration
lung cancer
staging
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases