NCT02398864

Brief Summary

To examine whether EBUS with transbronchial needle aspiration (TBNA) can accurately and safely diagnose enlarged lymph nodes in the chest in patients without suspected malignancy

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

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

March 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

2 years

First QC Date

March 13, 2015

Last Update Submit

March 20, 2015

Conditions

Mediastinal Lymphadenopathy

Outcome Measures

Primary Outcomes (1)

  • Sensitivity of EBUS-diagnosis

    Sensitivity defined as the proportion of participants with a positive EBUS-diagnosis accordant to final diagnosis, specificity, positive predictive value, negative predictive value and accuracy will be determined

    2 years

Secondary Outcomes (2)

  • Risk factors related with the development of complications

    2 years

  • Risk factors related with the procedure

    2 years

Study Arms (1)

endobronchial ultrasound bronchoscopy

EXPERIMENTAL

EBUS with TBNA

Procedure: EBUS with TBNA

Interventions

EBUS with TBNAPROCEDURE

endobronchial ultrasound (EBUS) with transbronchial needle aspiration (TBNA)

endobronchial ultrasound bronchoscopy

Eligibility Criteria

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

You may qualify if:

  • adults (18 Years and older) with mediastinal lymphadenopathy.

You may not qualify if:

  • known or suspected malignancy
  • no informed consent
  • pts with anterior mediastinal lesions
  • contraindications to EBUS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Thomas Fuehner, MD

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Fuehner, MD

CONTACT

+49 511 532fuehner.thomas@mh-hannover.de

Jens Gottlieb, MD

CONTACT

+49 511 532gottlieb.jens@mh-hannover.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2015

First Posted

March 26, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2017

Study Completion

June 1, 2017

Last Updated

March 26, 2015

Record last verified: 2015-03