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. 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
Information provided by:
Heidelberg University

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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

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

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 ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • enlarged mediastinal lymph nodes

Exclusion Criteria:

  • comorbidities

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 identifier (NCT number): NCT01145924

Contact: Felix JF Herth, PhD, MD +49 6221 396 ext 1200

Thoraxklinik Recruiting
Heidelberg, Germany, 69126
Contact: Ralf Eberhardt, MD    +49 6221 396 ext 8204   
Sub-Investigator: Ralf Eberhardt, MD         
Principal Investigator: Felix JF Herth, PhD, MD         
Sponsors and Collaborators
Heidelberg University
Study Director: Hendrik Dienemann, PhD, MD Heidelberg University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof. Felix JF Herth, Thoraxklinik Heidelberg Identifier: NCT01145924     History of Changes
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:
endobronchial ultrasound
transbronchial needle aspiration
lung cancer