Interest of Procore Needle® for Diagnosis of Lung Cancer
Primary Purpose
Endobronchial Transbronchial Needle Aspiration Lung Cancer Procore
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration
Sponsored by
About this trial
This is an interventional other trial for Endobronchial Transbronchial Needle Aspiration Lung Cancer Procore focused on measuring endobronchial transbronchial needle aspiration lung cancer procore
Eligibility Criteria
Inclusion Criteria:
- mediastinal lymphadenopathy >10 millimeters
- lung cancer suspected
Exclusion Criteria:
- coagulopathy contraindication for midazolam contraindication for bronchoscopy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
needle Procore ®
needle Cook®
Arm Description
Outcomes
Primary Outcome Measures
Proportion of histological diagnoses for each needle
Secondary Outcome Measures
Full Information
NCT ID
NCT02931461
First Posted
September 7, 2016
Last Updated
May 29, 2020
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02931461
Brief Title
Interest of Procore Needle® for Diagnosis of Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
October 27, 2016 (Actual)
Primary Completion Date
July 16, 2018 (Actual)
Study Completion Date
July 16, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
5. Study Description
Brief Summary
The ProCore ultrasound biopsy needle, used primarily to obtain intra-abdominal tissue core biopsies, has not been widely used for endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). In this study the investigators are going to evaluate the utility of the ProCore needle for sampling mediastinal or hilar lymph nodes during EBUS-TBNA versus standard 22 gauge needle for diagnosis of lung cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endobronchial Transbronchial Needle Aspiration Lung Cancer Procore
Keywords
endobronchial transbronchial needle aspiration lung cancer procore
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
49 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
needle Procore ®
Arm Type
Experimental
Arm Title
needle Cook®
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration
Primary Outcome Measure Information:
Title
Proportion of histological diagnoses for each needle
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
mediastinal lymphadenopathy >10 millimeters
lung cancer suspected
Exclusion Criteria:
coagulopathy contraindication for midazolam contraindication for bronchoscopy
12. IPD Sharing Statement
Learn more about this trial
Interest of Procore Needle® for Diagnosis of Lung Cancer
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