Liver NeoplasmsPhase 1/2NCT02521129
A New Track Ablation Device for Liver Biopsy: A Feasibility Study
A Phase 1/2 study testing Biopsy Track Ablator (STARmed, Goyang, Korea) in people with Liver Neoplasms, run by Samsung Medical Center.
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of a new biopsy track ablation device for liver biopsy. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Liver Neoplasms
- What is being tested?
- Biopsy Track Ablator (STARmed, Goyang, Korea)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Feb 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnant women
- patients with ascites
- Uncooperative patients
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Liver Neoplasms
- Being tested
- Biopsy Track Ablator (STARmed, Goyang, Korea)
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy Track Ablator (STARmed, Goyang, Korea)Device
Also called Ultrasound (Logig E9, GE Healthcare)
After percutaneous ultrasound guided biopsy for hepatic masses is performed, biopsy track is ablated with a new track ablation device.
| Study group | Role | What they receive |
|---|---|---|
| Ablation | Experimental | Intervention: ablation of biopsy needle track with a new device Receives: Device: Biopsy Track Ablator (STARmed, Goyang, Korea) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 24 hours after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver NeoplasmsStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyunchul Rhim, Samsung Medical Center
- Investigators
- Hyunchul Rhim, professor, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521129
- Sponsor's protocol ID
- 2014-11-048-003
- Other IDs
- GFO1130071
- Status last verified
- Aug 2015
- First submitted
- 3 Aug 2015
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
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 19243014Bruix 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Track Ablation Device for Liver Biopsy: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02521129
- Acronym / sponsor ID
- 2014-11-048-003
- Conditions
- Liver Neoplasms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ablation | Experimental | Device: Biopsy Track Ablator (STARmed, Goyang, Korea)Intervention: ablation of biopsy needle track with a new device |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- pregnant women
- patients with ascites
- Uncooperative patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsy Track Ablator (STARmed, Goyang, Korea)Also: Ultrasound (Logig E9, GE Healthcare)After percutaneous ultrasound guided biopsy for hepatic masses is performed, biopsy track is ablated with a new track ablation device. | Device | Ablation |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
- Background: PubMed 19243014Rockey 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.
- Background: PubMed 21374666Bruix 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyunchul Rhim, professor principal investigator
Samsung Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Biopsy Track Ablator (STARmed, Goyang, Korea) in people with Liver Neoplasms, run by Samsung Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyunchul Rhim, professor (82-2-3410-2507, hc.rhim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with complications (time frame: within 24 hours after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02521129, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2015.