NCT02931461

Brief Summary

The ProCore ultrasound biopsy needle, used primarily to obtain intra-abdominal tissue core biopsies, has not been widely used for endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). In this study the investigators are going to evaluate the utility of the ProCore needle for sampling mediastinal or hilar lymph nodes during EBUS-TBNA versus standard 22 gauge needle for diagnosis of lung cancer.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

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

First Submitted

Initial submission to the registry

September 7, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

October 27, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2018

Completed
Last Updated

June 2, 2020

Status Verified

May 1, 2020

Enrollment Period

1.7 years

First QC Date

September 7, 2016

Last Update Submit

May 29, 2020

Conditions

Endobronchial Transbronchial Needle Aspiration Lung Cancer Procore

Keywords

endobronchial transbronchial needle aspiration lung cancer procore

Outcome Measures

Primary Outcomes (1)

  • Proportion of histological diagnoses for each needle

    6 months

Study Arms (2)

needle Procore ®

EXPERIMENTAL
Procedure: Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration

needle Cook®

ACTIVE COMPARATOR
Procedure: Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration

Interventions

Endobronchial Ultrasound-Guided Transbronchial Needle AspirationPROCEDURE
needle Cook®needle Procore ®

Eligibility Criteria

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

You may qualify if:

  • mediastinal lymphadenopathy \>10 millimeters
  • lung cancer suspected

You may not qualify if:

  • coagulopathy contraindication for midazolam contraindication for bronchoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2016

First Posted

October 13, 2016

Study Start

October 27, 2016

Primary Completion

July 16, 2018

Study Completion

July 16, 2018

Last Updated

June 2, 2020

Record last verified: 2020-05