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A New Track Ablation Device for Liver Biopsy: A Feasibility Study

Primary Purpose

Liver Neoplasms

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Biopsy Track Ablator (STARmed, Goyang, Korea)
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Neoplasms

Eligibility Criteria

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

Inclusion Criteria:

  • patients with a hepatic mass on CT scan or MRI
  • patients who are referred for percutaneous biopsy of a hepatic mass
  • patients with normal range of platelet count and coagulation test

Exclusion Criteria:

  • pregnant women
  • patients with ascites
  • Uncooperative patients

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Ablation

    Arm Description

    Intervention: ablation of biopsy needle track with a new device

    Outcomes

    Primary Outcome Measures

    Number of participants with complications
    If procedure-related complications are suspected clinically, appropriate tests such as CT scan or Ultrasound are performed and complications are evaluated. If procedure-related complications are not suspected, non-contrast CT scan is performed at 24 hours after procedure and complications are evaluated.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 3, 2015
    Last Updated
    August 9, 2015
    Sponsor
    Samsung Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02521129
    Brief Title
    A New Track Ablation Device for Liver Biopsy: A Feasibility Study
    Official Title
    A New Track Ablation Device for Liver Biopsy: A Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    January 2016 (Anticipated)
    Study Completion Date
    February 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Samsung Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the effectiveness and safety of a new biopsy track ablation device for liver biopsy.
    Detailed Description
    Background: Percutaneous biopsy for hepatic masses has a potential risk of bleeding and peritoneal tumor seeding. A new device for biopsy track ablation has been invented to reduce the risk of bleeding and peritoneal tumor seeding. Method: Routine percutaneous biopsy for hepatic masses is performed. Immediate after obtaining tissue, biopsy needle track is ablated with a new biopsy tract ablator. Immediate (with ultrasound) and 24 hours (with CT scan) after procedure, occurrence of complications is evaluated.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Liver Neoplasms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ablation
    Arm Type
    Experimental
    Arm Description
    Intervention: ablation of biopsy needle track with a new device
    Intervention Type
    Device
    Intervention Name(s)
    Biopsy Track Ablator (STARmed, Goyang, Korea)
    Other Intervention Name(s)
    Ultrasound (Logig E9, GE Healthcare)
    Intervention Description
    After percutaneous ultrasound guided biopsy for hepatic masses is performed, biopsy track is ablated with a new track ablation device.
    Primary Outcome Measure Information:
    Title
    Number of participants with complications
    Description
    If procedure-related complications are suspected clinically, appropriate tests such as CT scan or Ultrasound are performed and complications are evaluated. If procedure-related complications are not suspected, non-contrast CT scan is performed at 24 hours after procedure and complications are evaluated.
    Time Frame
    within 24 hours after procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with a hepatic mass on CT scan or MRI patients who are referred for percutaneous biopsy of a hepatic mass patients with normal range of platelet count and coagulation test Exclusion Criteria: pregnant women patients with ascites Uncooperative patients
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hyunchul Rhim, professor
    Phone
    82-2-3410-2507
    Email
    hc.rhim@samsung.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kyoung Doo Song, professor
    Phone
    82-2-3410-2519
    Email
    kd3893.song@samsung.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hyunchul Rhim, professor
    Organizational Affiliation
    Samsung Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19243014
    Citation
    Rockey DC, Caldwell SH, Goodman ZD, Nelson RC, Smith AD; American Association for the Study of Liver Diseases. Liver biopsy. Hepatology. 2009 Mar;49(3):1017-44. doi: 10.1002/hep.22742. No abstract available.
    Results Reference
    background
    PubMed Identifier
    21374666
    Citation
    Bruix J, Sherman M; American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma: an update. Hepatology. 2011 Mar;53(3):1020-2. doi: 10.1002/hep.24199. No abstract available.
    Results Reference
    background

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    A New Track Ablation Device for Liver Biopsy: A Feasibility Study

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