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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
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 7, 2016
    Last Updated
    May 29, 2020
    Sponsor
    Poitiers University Hospital
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    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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