NCT02521129

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Neoplasms

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-01-01
• Completion: 2016-02-01
• First posted: 2015-08-13
• Last updated: 2015-08-13