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Clinical Trial Summary

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


Clinical Trial 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. ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02521129
Study type Interventional
Source Samsung Medical Center
Contact Hyunchul Rhim, professor
Phone 82-2-3410-2507
Email hc.rhim@samsung.com
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date September 2015
Completion date February 2016

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