Transbronchial Needle Forceps for Endobronchial Ultrasound

June 16, 2010 updated by: Heidelberg University

Transbronchial Needle Forceps for EBUS

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • enlarged mediastinal lymph nodes

Exclusion Criteria:

  • comorbidities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Endobronchial ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with a positive biopsy result
Time Frame: 2 days after intervention
2 days after intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 3 weeks after
3 weeks after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Investigators

  • Study Director: Hendrik Dienemann, PhD, MD, Heidelberg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

August 1, 2010

Study Completion (Anticipated)

August 1, 2010

Study Registration Dates

First Submitted

June 7, 2010

First Submitted That Met QC Criteria

June 16, 2010

First Posted (Estimate)

June 17, 2010

Study Record Updates

Last Update Posted (Estimate)

June 17, 2010

Last Update Submitted That Met QC Criteria

June 16, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HD 08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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