A New Track Ablation Device for Liver Biopsy: A Feasibility Study
2 other identifiers
interventional
20
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of a new biopsy track ablation device for liver biopsy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2015
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2015
CompletedFirst Posted
Study publicly available on registry
August 13, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedAugust 13, 2015
August 1, 2015
4 months
August 3, 2015
August 9, 2015
Conditions
Outcome Measures
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.
within 24 hours after procedure
Study Arms (1)
Ablation
EXPERIMENTALIntervention: ablation of biopsy needle track with a new device
Interventions
After percutaneous ultrasound guided biopsy for hepatic masses is performed, biopsy track is ablated with a new track ablation device.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- pregnant women
- patients with ascites
- Uncooperative patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 19243014BACKGROUNDBruix 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.
PMID: 21374666BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyunchul Rhim, professor
Samsung Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
August 3, 2015
First Posted
August 13, 2015
Study Start
September 1, 2015
Primary Completion
January 1, 2016
Study Completion
February 1, 2016
Last Updated
August 13, 2015
Record last verified: 2015-08