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NCT01145924 Clinical Trial

Transbronchial Needle Forceps for Endobronchial Ultrasound

Lung Cancer Clinical Trial

Official title:
Transbronchial Needle Forceps for EBUS

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT01145924
Other study ID # HD 08
Secondary ID
Status Unknown status
Phase Phase 2
First received June 7, 2010
Last updated June 16, 2010
Start date January 2010
Est. completion date August 2010

Study information
Verified date February 2010
Source Heidelberg University
Contact Felix JF Herth, PhD, MD
Phone +49 6221 396
Email Felix.Herth@thoraxklinik-heidelberg.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prove the feasibility of a needle forceps in patients with enlarged mediastinal lymph nodes

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

Recruitment information / eligibility
Status Unknown status
Enrollment 50
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- enlarged mediastinal lymph nodes

Exclusion Criteria:

- comorbidities

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• EBUS TBNF
Transbronchial needle forceps will be use with the EBUS TBNA scope

Locations
Country Name City State
Germany Thoraxklinik Heidelberg

Sponsors (1)
Lead Sponsor Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants with a positive biopsy result 2 days after intervention
Secondary Number of Participants with Adverse Events as a Measure of Safety and Tolerability 3 weeks after
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