Transbronchial Needle Forceps for Endobronchial Ultrasound

NCT ID: NCT01145924

Last Updated: 2010-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-08-31

Brief Summary

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

Detailed Description

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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

Conditions

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Lung Cancer Lymph Nodes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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EBUS TBNF

single arm trial, patients with enlarged mediastinal nodes will be examine

Group Type ACTIVE_COMPARATOR

EBUS TBNF

Intervention Type PROCEDURE

Transbronchial needle forceps will be use with the EBUS TBNA scope

Interventions

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EBUS TBNF

Transbronchial needle forceps will be use with the EBUS TBNA scope

Intervention Type PROCEDURE

Other Intervention Names

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Endobronchial ultrasound

Eligibility Criteria

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Inclusion Criteria

* enlarged mediastinal lymph nodes

Exclusion Criteria

* comorbidities
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Thoraxklinik Heidelberg

Principal Investigators

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Hendrik Dienemann, PhD, MD

Role: STUDY_DIRECTOR

Heidelberg University

Locations

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Thoraxklinik

Heidelberg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Felix JF Herth, PhD, MD

Role: CONTACT

+49 6221 396 ext. 1200

Facility Contacts

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Ralf Eberhardt, MD

Role: primary

+49 6221 396 ext. 8204

References

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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.

Reference Type DERIVED
PMID: 21700609 (View on PubMed)

Other Identifiers

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HD 08

Identifier Type: -

Identifier Source: org_study_id

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