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Status unknownNCT02521129Updated Aug 13, 2015

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

A Phase 1/2 interventional study of Biopsy Track Ablator (STARmed, Goyang, Korea) in Liver Neoplasms, sponsored by Samsung Medical Center. Status unknown. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-08-13.

Sponsored by Samsung Medical Center · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
20 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.
02

Conditions studied

  • Liver Neoplasms

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03

In context

Liver Neoplasms

1,390 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.

This study's planned enrollment of 20 is below the median of 47 across 967 interventional studies indexed under Liver Neoplasms.

Browse Liver Neoplasms studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • pregnant women
  • patients with ascites
  • Uncooperative patients
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Ablation

    Intervention: ablation of biopsy needle track with a new device

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

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.

    Also known as: Ultrasound (Logig E9, GE Healthcare)

06

What researchers measure

Primary outcomes

  1. Number of participants with complications

    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.

    Time frame: within 24 hours after procedure

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Rockey DC, Caldwell SH, Goodman ZD, Nelson RC, Smith AD; American Association for the Study of Liver Diseases. Liver biopsy. Hepatology. 2009 Mar;49(3):1017-44. doi: 10.1002/hep.22742. No abstract available. PubMed 19243014 ↗
  • Bruix J, Sherman M; American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma: an update. Hepatology. 2011 Mar;53(3):1020-2. doi: 10.1002/hep.24199. No abstract available. PubMed 21374666 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02521129
Lead sponsor
Samsung Medical Center
Responsible party
Hyunchul Rhim (professor, Samsung Medical Center) — Principal investigator
First posted
Aug 13, 2015
Start date
Sep 2015
Primary completion
Jan 2016 (estimated)
Completion
Feb 2016 (estimated)
Last update
Aug 13, 2015

Study contacts

Hyunchul Rhim, professor
Contact
hc.rhim@samsung.com
82-2-3410-2507
Kyoung Doo Song, professor
Contact
kd3893.song@samsung.com
82-2-3410-2519
Hyunchul Rhim, professor
principal investigator · Samsung Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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