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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-02-29

Brief Summary

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The purpose of this study is to evaluate the effectiveness and safety of a new biopsy track ablation device for liver biopsy.

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Detailed Description

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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.

Conditions

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Liver Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ablation

Intervention: ablation of biopsy needle track with a new device

Group Type EXPERIMENTAL

Biopsy Track Ablator (STARmed, Goyang, Korea)

Intervention Type DEVICE

After percutaneous ultrasound guided biopsy for hepatic masses is performed, biopsy track is ablated with a new track ablation device.

Interventions

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Biopsy Track Ablator (STARmed, Goyang, Korea)

After percutaneous ultrasound guided biopsy for hepatic masses is performed, biopsy track is ablated with a new track ablation device.

Intervention Type DEVICE

Other Intervention Names

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Ultrasound (Logig E9, GE Healthcare)

Eligibility Criteria

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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