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

Liver Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02521129
• Other study ID #: 2014-11-048-003
• Secondary ID: GFO1130071
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: August 3, 2015
• Last updated: August 9, 2015
• Start date: September 2015
• Est. completion date: February 2016

Study information

• Verified date: August 2015
• Source: Samsung Medical Center
• Contact: Hyunchul Rhim, professor
• Phone: 82-2-3410-2507
• Email: hc.rhim[@]samsung.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Liver Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	within 24 hours after procedure	Yes