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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-12-19

Brief Summary

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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

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

22-gauge Standard Needle

Intervention Type OTHER

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 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)

Group Type ACTIVE_COMPARATOR

22-gauge ProCore Needle

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No