Transbronchial Needle Forceps for Endobronchial Ultrasound

Phase 2

• Conditions: Lung Cancer; Lymph Nodes
• Interventions: Procedure: EBUS TBNF

• Registration Number: NCT01145924
• Lead Sponsor: Heidelberg University

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

Study Timeline

• Study Start: 2010-01
• Status Verified: 2010-02
• Study First Submitted: 2010-06-07
• Study First Submitted QC: 2010-06-16
• Last Update Submitted: 2010-06-16
• Study First Posted: 2010-06-17
• Last Update Posted: 2010-06-17
• Primary Completion: 2010-08
• Study Completion: 2010-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• enlarged mediastinal lymph nodes

Exclusion Criteria

• comorbidities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EBUS TBNF	EBUS TBNF	single arm trial, patients with enlarged mediastinal nodes will be examine

Primary Outcome Measures

Name	Time	Method
Number of Participants with a positive biopsy result	2 days after intervention

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	3 weeks after

Trial Locations

Locations (1)

Thoraxklinik; 🇩🇪 Heidelberg, Germany