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

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

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02521129
Enrollment
20
Registered
2015-08-13
Start date
2015-09-30
Completion date
2016-02-29
Last updated
2015-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Neoplasms

Brief 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.

Interventions

DEVICEBiopsy 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.

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with complicationswithin 24 hours after procedureIf 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.

Contacts

Primary ContactHyunchul Rhim, professor
hc.rhim@samsung.com82-2-3410-2507
Backup ContactKyoung Doo Song, professor
kd3893.song@samsung.com82-2-3410-2519

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026