22-gauge ProCore Needle v. Standard 22-gauge (P00030500)

A Multi-center Study Comparing Standard 22-gauge and 22-gauge ProCore Needles for Endobronchial Ultrasound

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

Study Overview

• Status: Completed
• Conditions: Quantity of Tissue Obtained; Quality of Tissue Obtained; Ease of Use of 22-gauge ProCore EBUS Needles and the Standard 22-gauge Needles
• Intervention / Treatment: Other: 22-gauge Standard Needle; Other: 22-gauge ProCore Needle

Detailed Description

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. Both of these needles are used to get biopsies (samples) of lung tissue. The standard needle has one bevel (angled side of the needle formed when it is sharpened to make a point), while the ProCore needle has 2 bevels. The standard needle is more commonly used and we are doing this study to see if the ProCore needle would be more useful.

The investigator in charge of this study is Dr. Nichole T. Tanner. This study is being done at four sites and will involve approximately 200 volunteers.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida
  • Maryland
    • Baltimore, Maryland, United States
      • Johns Hopkins University
  • North Carolina
    • Chapel Hill, North Carolina, United States
      • University of North Carolina Medical School
  • South Carolina
    • Charleston, South Carolina, United States
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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.
2. 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.

Exclusion Criteria:

1. Subjects who refuse to participate, or demonstrate inability to give informed consent
2. Subjects who are less than 18 years of age
3. Subjects who lack fitness for flexible bronchoscopy as determined by the physician performing the bronchoscopy before the procedure
4. Subjects with suspected sarcoidosis, lymphoma, or metastatic cancer from other sites (i.e. those without a known or suspected lung primary)
5. 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 22-gauge Standard Needle; 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; Acquisition of lymph nodes samples using the 22-gauge Standard Needle, following subject-sedation and the introduction of an EBUS scope into the airway.
Active Comparator: 22-gauge ProCore Needle; 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; Acquisition of lymph nodes samples using the 22-gauge ProCore Needle, following subject-sedation and the introduction of an EBUS scope into the airway.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: Johns Hopkins University; University of North Carolina; Cook Endoscopy; Thoraxklinik-Heidelberg gGmbH
• Investigators: Principal Investigator: Nichole T Tanner, MD, M.S.C.R, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): December 19, 2017
• Study Completion (Actual): December 19, 2017

Study Registration Dates

• First Submitted: May 22, 2014
• First Submitted That Met QC Criteria: May 30, 2014
• First Posted (Estimate): June 3, 2014

Study Record Updates

• Last Update Posted (Actual): April 30, 2018
• Last Update Submitted That Met QC Criteria: April 27, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 00030500