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

August 9, 2015 updated by: Hyunchul Rhim, Samsung Medical Center
The purpose of this study is to evaluate the effectiveness and safety of a new biopsy track ablation device for liver biopsy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ablation
Intervention: ablation of biopsy needle track with a new device
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.
Other Names:
  • Ultrasound (Logig E9, GE Healthcare)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with complications
Time Frame: 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.
within 24 hours after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Hyunchul Rhim, professor, Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

August 3, 2015

First Submitted That Met QC Criteria

August 9, 2015

First Posted (Estimate)

August 13, 2015

Study Record Updates

Last Update Posted (Estimate)

August 13, 2015

Last Update Submitted That Met QC Criteria

August 9, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-11-048-003
  • GFO1130071 (Other Grant/Funding Number: Samsung Medical Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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