NCT02154698

Brief Summary

The purpose of this study is to compare the usefulness of two needles (used for obtaining a lung tissue sample : (1) standard 22-gauge, and (2) ProCore 22-gauge) for endobronchial ultrasound

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

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

May 22, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2017

Completed
Last Updated

April 30, 2018

Status Verified

April 1, 2018

Enrollment Period

3.6 years

First QC Date

May 22, 2014

Last Update Submit

April 27, 2018

Conditions

Quantity of Tissue ObtainedQuality of Tissue ObtainedEase of Use of 22-gauge ProCore EBUS Needles and the Standard 22-gauge Needles

Outcome Measures

Primary Outcomes (3)

  • Ease of use of 22-gauge ProCore EBUS needles and the standard 22-gauge needles.

    Within two weeks from the day of the procedure

  • Quality of tumor obtained (measured by cell block and ability to perform mutational analysis)

    Within two weeks from the day of the procedure

  • Quantity of tissue obtained (measured by number of unstructured fragments)

    Within two weeks from the day of the procedure

Study Arms (2)

22-gauge Standard Needle

ACTIVE COMPARATOR

Participants will have each node sampled starting with the standard 22G needle on the first pass followed by the ProCore 22G needle on the second pass (for a total of 8 passes)

Other: 22-gauge Standard Needle

22-gauge ProCore Needle

ACTIVE COMPARATOR

Participants will have each node sampled starting with the ProCore 22G on the first pass followed by the standard 22G needle on the second pass (for a total of 8 passes)

Other: 22-gauge ProCore Needle

Interventions

22-gauge Standard NeedleOTHER

Acquisition of lymph nodes samples using the 22-gauge Standard Needle, following subject-sedation and the introduction of an EBUS scope into the airway.

22-gauge Standard Needle
22-gauge ProCore NeedleOTHER

Acquisition of lymph nodes samples using the 22-gauge ProCore Needle, following subject-sedation and the introduction of an EBUS scope into the airway.

22-gauge ProCore Needle

Eligibility Criteria

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

You may qualify if:

  • Subjects with known or suspected lung cancer with mediastinal adenopathy as defined by a mediastinal lymph node \>1 cm in short axis or a normal sized lymph node with uptake on FDG-PET scan that is higher than background PET activity.
  • Participants must be at least 18 years old or older, lack bleeding disorders, and be able to provide informed consent. The latter two criteria will be assessed from the patient's history and the consenting interview.

You may not qualify if:

  • Subjects who refuse to participate, or demonstrate inability to give informed consent
  • Subjects who are less than 18 years of age
  • Subjects who lack fitness for flexible bronchoscopy as determined by the physician performing the bronchoscopy before the procedure
  • Subjects with suspected sarcoidosis, lymphoma, or metastatic cancer from other sites (i.e. those without a known or suspected lung primary)
  • Subjects on anticoagulation (other than Aspirin) whom cannot have their anticoagulation held for the procedure due to other clinical reasons (i.e. recent cardiac stent placement).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Florida

Gainesville, Florida, 32611, United States

Location

Johns Hopkins University

Baltimore, Maryland, United States

Location

University of North Carolina Medical School

Chapel Hill, North Carolina, United States

Location

Medical University of South Carolina

Charleston, South Carolina, United States

Location

Study Officials

  • Nichole T Tanner, MD, M.S.C.R

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2014

First Posted

June 3, 2014

Study Start

June 1, 2014

Primary Completion

December 19, 2017

Study Completion

December 19, 2017

Last Updated

April 30, 2018

Record last verified: 2018-04

Locations

US(4)