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Transbronchial Needle Forceps for Endobronchial Ultrasound

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by University of Heidelberg.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01145924
First received: June 7, 2010
Last updated: June 16, 2010
Last verified: February 2010
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Transbronchial Needle Forceps for EBUS

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:
  • Number of Participants with a positive biopsy result [ Time Frame: 2 days after intervention ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • enlarged mediastinal lymph nodes

Exclusion Criteria:

  • comorbidities
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
University of Heidelberg
Investigators
Study Director: Hendrik Dienemann, PhD, MD University of Heidelberg
  More Information

No publications provided by University of Heidelberg

Additional 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
Study First Received: June 7, 2010
Last Updated: June 16, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013