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Transbronchial Needle Forceps for Endobronchial Ultrasound

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2010 by Heidelberg University.
Recruitment status was:  Recruiting
Information provided by:
Heidelberg University Identifier:
First received: June 7, 2010
Last updated: June 16, 2010
Last verified: February 2010
Prove the feasibility of a needle forceps in patients with enlarged mediastinal lymph nodes

Condition Intervention Phase
Lung Cancer Lymph Nodes Procedure: EBUS TBNF Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Transbronchial Needle Forceps for EBUS

Resource links provided by NLM:

Further study details as provided by Heidelberg University:

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

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

Estimated Enrollment: 50
Study Start Date: January 2010
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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

Inclusion Criteria:

  • enlarged mediastinal lymph nodes

Exclusion Criteria:

  • comorbidities
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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
Study First Received: June 7, 2010
Last Updated: June 16, 2010

Keywords provided by Heidelberg University:
endobronchial ultrasound
transbronchial needle aspiration
lung cancer
staging processed this record on September 21, 2017