22-gauge ProCore Needle v. Standard 22-gauge (P00030500)
Completed · Not applicable
Conditions studied: Quantity of Tissue Obtained, Quality of Tissue Obtained, Ease of Use of 22-gauge ProCore EBUS Needles and the Standard 22-gauge Needles
In brief
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
Key facts
- Study ID
- NCT02154698
- Run by
- Medical University of South Carolina
- People needed
- 200
- Starts
- 2014-06-01
- Expected to finish
- 2017-12-19
- Last updated by the study team
- 2018-04-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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).
Where it is running
- University of Florida — Gainesville, Florida, United States
- Johns Hopkins University — Baltimore, Maryland, United States
- University of North Carolina Medical School — Chapel Hill, North Carolina, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
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