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

Phase 1

• Conditions: Liver Neoplasms
• Interventions: Device: Biopsy Track Ablator (STARmed, Goyang, Korea)

• Registration Number: NCT02521129
• Lead Sponsor: Samsung Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2015-08
• Study First Submitted: 2015-08-03
• Study First Submitted QC: 2015-08-09
• Last Update Submitted: 2015-08-09
• Study First Posted: 2015-08-13
• Last Update Posted: 2015-08-13
• Study Start: 2015-09
• Primary Completion: 2016-01
• Study Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

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Exclusion Criteria

• pregnant women
• patients with ascites
• Uncooperative patients

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ablation	Biopsy Track Ablator (STARmed, Goyang, Korea)	Intervention: ablation of biopsy needle track with a new device

Primary Outcome Measures

Name	Time	Method
Number of participants with complications	within 24 hours after procedure	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.