NCT01145924

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_2 lung-cancer

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_2 lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2010

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 17, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

June 17, 2010

Status Verified

February 1, 2010

Enrollment Period

7 months

First QC Date

June 7, 2010

Last Update Submit

June 16, 2010

Conditions

Lung CancerLymph Nodes

Keywords

bronchoscopyendobronchial ultrasoundtransbronchial needle aspirationlung cancerstaging

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with a positive biopsy result

    2 days after intervention

Secondary Outcomes (1)

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    3 weeks after

Study Arms (1)

EBUS TBNF

ACTIVE COMPARATOR

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

Procedure: EBUS TBNF

Interventions

EBUS TBNFPROCEDURE

Transbronchial needle forceps will be use with the EBUS TBNA scope

Also known as: Endobronchial ultrasound
EBUS TBNF

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • enlarged mediastinal lymph nodes

You may not qualify if:

  • comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thoraxklinik

Heidelberg, 69126, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 21700609DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Hendrik Dienemann, PhD, MD

    Heidelberg University

    STUDY DIRECTOR

Central Study Contacts

Felix JF Herth, PhD, MD

CONTACT

+49 6221 396Felix.Herth@thoraxklinik-heidelberg.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 7, 2010

First Posted

June 17, 2010

Study Start

January 1, 2010

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

June 17, 2010

Record last verified: 2010-02

Locations

DE(1)