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

Samsung Medical Center

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Liver Neoplasms

Treatments: Device: Biopsy Track Ablator (STARmed, Goyang, Korea)

Study type: Interventional

Funder types: Other

Identifiers

NCT02521129

2014-11-048-003

GFO1130071 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Ablation

Experimental group

Description:

Intervention: ablation of biopsy needle track with a new device

Treatment:

Device: Biopsy Track Ablator (STARmed, Goyang, Korea)