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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02154698

Enrollment

200

Registered

2014-06-03

Start date

2014-06-30

Completion date

2017-12-19

Last updated

2018-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ease of Use of 22-gauge ProCore EBUS Needles and the Standard 22-gauge Needles, Quality of Tissue Obtained, Quantity of Tissue Obtained

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

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.

Interventions

OTHER22-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.

OTHER22-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026