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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01145924
First Posted: June 17, 2010
Last Update Posted: October 12, 2017
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.
Information provided by:
Heidelberg University
  Purpose
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
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • enlarged mediastinal lymph nodes

Exclusion Criteria:

  • comorbidities
  Contacts and Locations
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
Contact: Felix JF Herth, PhD, MD +49 6221 396 ext 1200 Felix.Herth@thoraxklinik-heidelberg.de

Locations
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
Study Director: Hendrik Dienemann, PhD, MD Heidelberg University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Felix JF Herth, Thoraxklinik Heidelberg
ClinicalTrials.gov Identifier: NCT01145924     History of Changes
Other Study ID Numbers: HD 08
First Submitted: June 7, 2010
First Posted: June 17, 2010
Last Update Posted: October 12, 2017
Last Verified: February 2010

Keywords provided by Heidelberg University:
bronchoscopy
endobronchial ultrasound
transbronchial needle aspiration
lung cancer
staging