Back to resultsTransbronchial Needle Forceps for Endobronchial Ultrasound
Primary Purpose
Lung Cancer, Lymph Nodes
Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
EBUS TBNF
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Cancer focused on measuring bronchoscopy, endobronchial ultrasound, transbronchial needle aspiration, lung cancer, staging
Eligibility Criteria
Inclusion Criteria:
- enlarged mediastinal lymph nodes
Exclusion Criteria:
- comorbidities
Sites / Locations
- ThoraxklinikRecruiting
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
EBUS TBNF
Arm Description
single arm trial, patients with enlarged mediastinal nodes will be examine
Outcomes
Primary Outcome Measures
Number of Participants with a positive biopsy result
Secondary Outcome Measures
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01145924
Brief Title
Transbronchial Needle Forceps for Endobronchial Ultrasound
Official Title
Transbronchial Needle Forceps for EBUS
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
August 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Heidelberg University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Prove the feasibility of a needle forceps in patients with enlarged mediastinal lymph nodes
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Lymph Nodes
Keywords
bronchoscopy, endobronchial ultrasound, transbronchial needle aspiration, lung cancer, staging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EBUS TBNF
Arm Type
Active Comparator
Arm Description
single arm trial, patients with enlarged mediastinal nodes will be examine
Intervention Type
Procedure
Intervention Name(s)
EBUS TBNF
Other Intervention Name(s)
Endobronchial ultrasound
Intervention Description
Transbronchial needle forceps will be use with the EBUS TBNA scope
Primary Outcome Measure Information:
Title
Number of Participants with a positive biopsy result
Time Frame
2 days after intervention
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
3 weeks after
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
enlarged mediastinal lymph nodes
Exclusion Criteria:
comorbidities
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Felix JF Herth, PhD, MD
Phone
+49 6221 396
Ext
1200
Email
Felix.Herth@thoraxklinik-heidelberg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hendrik Dienemann, PhD, MD
Organizational Affiliation
Heidelberg University
Official's Role
Study Director
Facility Information:
Facility Name
Thoraxklinik
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralf Eberhardt, MD
Phone
+49 6221 396
Ext
8204
Email
Ralf.Eberhardt@thoraxklinik-heidelberg.de
First Name & Middle Initial & Last Name & Degree
Ralf Eberhardt, MD
First Name & Middle Initial & Last Name & Degree
Felix JF Herth, PhD, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
21700609
Citation
Herth FJ, Schuler H, Gompelmann D, Kahn N, Gasparini S, Ernst A, Schuhmann M, Eberhardt R. Endobronchial ultrasound-guided lymph node biopsy with transbronchial needle forceps: a pilot study. Eur Respir J. 2012 Feb;39(2):373-7. doi: 10.1183/09031936.00033311. Epub 2011 Jun 23.
Results Reference
derived
Learn more about this trial
Transbronchial Needle Forceps for Endobronchial Ultrasound
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