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CT-guided Needle Guidance Using Stereotaxic Unit, Navigation Versus Conventional Biopsy Technique for the Percutaneous Pulmonary Nodule Biopsy

Primary Purpose

Percutaneous Pulmonary Nodule Biopsy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
stereotaxic unit, navigation
conventional biopsy technique
Sponsored by
Hyung Jin Won
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Percutaneous Pulmonary Nodule Biopsy

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient with localized lesions such as pulmonary nodules on chest x-ray, CT or PET CT
  • Histopathologic examination is necessary if lung lesion is unknown
  • Histologic findings affect the disease stage or treatment plan
  • If the investigator decides to perform a percutaneous lung biopsy because the biopsy or diagnosis through the bronchoscopy is not possible or has low risk-benefit
  • Patient who have consented to contraception during the period of clinical trial participation (one month after the procedure)
  • Patient who voluntarily agree to participate in this clinical trial and are willing to comply with the protocol

Exclusion Criteria:

  • Patient with pulmonary function insufficiency
  • Patient who has difficulty in self-breathing (e.g, breathing through oxygen breathing apparatus)
  • Patient with Uncontrolled coagulation disorders (INR > 1.3 or Blood platelet count < 50,000/µl)
  • Patient with allergy to CT contrast agent
  • Patient under 19 years old or over 80 years old
  • Pregnant or lactating
  • Patient with uncontrollable systemic disease (e.g, uncontrolled hypertension, uncontrolled cardiovascular disease, etc.)
  • Patient who currently participating or has participated in other clinical trials within 30 days of the screening date
  • If it is judged inappropriate to participate in this clinical trial under the judgment of the investigator

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Stereotaxic unit, navigation

    Conventional biopsy technique

    Arm Description

    Outcomes

    Primary Outcome Measures

    Needle guide accuracy(mm)
    3D distance between target point and actual needle tip

    Secondary Outcome Measures

    Needle guide angle deviation(°)
    The angle deviation between the needle insertion path on the procedure plan and the path of the actually inserted needle
    Number of needle readjustments
    Retract the inserted needle and adjust the direction
    Number of needle reinsertion
    Needle is completely pulled out and then inserted again
    Needle insertion time(min)
    Time from pre-CT scan to the last CT scan before lung biopsy
    Procedure time(min)
    Time from pre-CT scan to dressing after lung biopsy

    Full Information

    First Posted
    October 23, 2017
    Last Updated
    October 24, 2017
    Sponsor
    Hyung Jin Won
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03321994
    Brief Title
    CT-guided Needle Guidance Using Stereotaxic Unit, Navigation Versus Conventional Biopsy Technique for the Percutaneous Pulmonary Nodule Biopsy
    Official Title
    A Single-center, Randomized, Active-controlled and Evaluator-blind Investigator-initiated Trial to Evaluate and Compare the Efficacy and Safety of CT-guided Needle Guidance Using Stereotaxic Unit, Navigation Versus Conventional Biopsy Technique for the Patients Scheduled to Undergo Percutaneous Pulmonary Nodule Biopsy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2017 (Anticipated)
    Primary Completion Date
    June 2019 (Anticipated)
    Study Completion Date
    June 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Hyung Jin Won

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The purpose of this study was to compare the safety and efficacy of CT-guided needle guidance using stereotaxic unit, navigation versus conventional biopsy technique for the patients scheduled to undergo percutaneous pulmonary nodule biopsy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Percutaneous Pulmonary Nodule Biopsy

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    106 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Stereotaxic unit, navigation
    Arm Type
    Experimental
    Arm Title
    Conventional biopsy technique
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    stereotaxic unit, navigation
    Intervention Description
    CT-guided needle guidance using stereotaxic unit, navigation
    Intervention Type
    Device
    Intervention Name(s)
    conventional biopsy technique
    Intervention Description
    CT-guided needle guidance using conventional biopsy technique
    Primary Outcome Measure Information:
    Title
    Needle guide accuracy(mm)
    Description
    3D distance between target point and actual needle tip
    Time Frame
    1 day
    Secondary Outcome Measure Information:
    Title
    Needle guide angle deviation(°)
    Description
    The angle deviation between the needle insertion path on the procedure plan and the path of the actually inserted needle
    Time Frame
    1 day
    Title
    Number of needle readjustments
    Description
    Retract the inserted needle and adjust the direction
    Time Frame
    1 day
    Title
    Number of needle reinsertion
    Description
    Needle is completely pulled out and then inserted again
    Time Frame
    1 day
    Title
    Needle insertion time(min)
    Description
    Time from pre-CT scan to the last CT scan before lung biopsy
    Time Frame
    1 day
    Title
    Procedure time(min)
    Description
    Time from pre-CT scan to dressing after lung biopsy
    Time Frame
    1 day
    Other Pre-specified Outcome Measures:
    Title
    Radiation dose(DLP, mGy·cm)
    Description
    DLP(mGy·cm) = CTDIvol x scan length
    Time Frame
    1 day
    Title
    Occurrence rate of adverse device effect(%)
    Description
    Adverse events that are correlated with the needle insertion procedure
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient with localized lesions such as pulmonary nodules on chest x-ray, CT or PET CT Histopathologic examination is necessary if lung lesion is unknown Histologic findings affect the disease stage or treatment plan If the investigator decides to perform a percutaneous lung biopsy because the biopsy or diagnosis through the bronchoscopy is not possible or has low risk-benefit Patient who have consented to contraception during the period of clinical trial participation (one month after the procedure) Patient who voluntarily agree to participate in this clinical trial and are willing to comply with the protocol Exclusion Criteria: Patient with pulmonary function insufficiency Patient who has difficulty in self-breathing (e.g, breathing through oxygen breathing apparatus) Patient with Uncontrolled coagulation disorders (INR > 1.3 or Blood platelet count < 50,000/µl) Patient with allergy to CT contrast agent Patient under 19 years old or over 80 years old Pregnant or lactating Patient with uncontrollable systemic disease (e.g, uncontrolled hypertension, uncontrolled cardiovascular disease, etc.) Patient who currently participating or has participated in other clinical trials within 30 days of the screening date If it is judged inappropriate to participate in this clinical trial under the judgment of the investigator
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hyung Jin Won, MD., PhD
    Phone
    82-2-3010-4352
    Email
    hyungjin.won@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sang Young Oh, MD., PhD
    Phone
    82-2-3010-4352
    Email
    ojangsa@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hyung Jin Won, MD., PhD
    Organizational Affiliation
    Asan Medical Center, Seoul, Korea
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    CT-guided Needle Guidance Using Stereotaxic Unit, Navigation Versus Conventional Biopsy Technique for the Percutaneous Pulmonary Nodule Biopsy

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