NCT01734980

Brief Summary

Cytological diagnostic accuracy between endobronchial ultrasonography endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) samples using suction versus samples when no suction is applied.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2012

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 28, 2012

Completed
Last Updated

November 28, 2012

Status Verified

November 1, 2012

Enrollment Period

9 months

First QC Date

July 4, 2012

Last Update Submit

November 25, 2012

Conditions

Mediastinal LymphadenopathyLung Malignancies

Keywords

Endobronchial Ultrasoundtransbronchial needle aspiration

Outcome Measures

Primary Outcomes (1)

  • Diagnostic yield

    The number of patients with cytological diagnosis as a measure of effective diagnostic technique.

    3 days

Secondary Outcomes (1)

  • Samples adequacy

    3 days

Study Arms (1)

Endobronchial Ultrasound

EXPERIMENTAL

EBUS-TBNA is a procedure that allows accurate sampling of mediastinal lymph nodes and peribronchial lesions

Procedure: Endobronchial Ultrasound

Interventions

Endobronchial UltrasoundPROCEDURE

The samples will be divided as 2 groups for comparison. Group A is the group of samples where we apply negative pressure syringe for needle suction. Group B is where no suction will be applied after needle insertion.

Endobronchial Ultrasound

Eligibility Criteria

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

You may qualify if:

  • All adult subjects who are scheduled to undergo endobronchial ultrasound transbronchial aspiration to sample mediastinal masses or lymph nodes.

You may not qualify if:

  • Patients who are not able to complete the EBUS procedure for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Michel Chalhoub, MD

    Staten Island University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 4, 2012

First Posted

November 28, 2012

Study Start

February 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

November 28, 2012

Record last verified: 2012-11

Locations

US(1)