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

Medical University of South Carolina (MUSC)

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

Treatments: Other: 22-gauge Standard Needle; Other: 22-gauge ProCore Needle

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02154698

00030500

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

22-gauge Standard Needle

Active Comparator group

Description:

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)

Treatment:

Other: 22-gauge Standard Needle

22-gauge ProCore Needle

Active Comparator group

Description:

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)

Treatment:

Other: 22-gauge ProCore Needle