BleedingNCT05017350
Hemostasis Using Radiofrequency Ablation for Track Bleeding
A study testing radiofrequency ablation in people with Bleeding, run by Kyoung Doo Song at 1 site in South Korea.
Trial summary
This study aims to evaluate the usefulness of hemostasis using radiofrequency ablation for track bleeding that has occurred after percutaneous biopsy of the liver. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Bleeding
- What is being tested?
- radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2021to 31 Dec 2024
- Phase
- Interventional
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ultrasound guided percutaneous liver biopsy at Samsung Medical Center
- Track bleeding after biopsy
- Persistent track bleeding even after conservative management
- Consent to this study
Who cannot join
- Not consent to this study
- <20 years old or >=80 years old
- Contraindication to radiofrequency ablation
- Radiofrequency ablation for track bleeding is not technically possible.
- Unstable vital signs
Trial locations and contacts
1 site in 1 country.
Min Woo Lee, Professor contact
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Kyoung Doo Song, Professor, kd3893.song@samsung.com
About this study
Official title: Hemostasis Using Radiofrequency Ablation for Track Bleeding After Liver Biopsy
This study aims to evaluate the usefulness of hemostasis using radiofrequency ablation for track bleeding that has occurred after percutaneous biopsy of the liver.
Read the detailed description
Purpose: To evaluate the usefulness of hemostasis using radiofrequency ablation for track bleeding after percutaneous liver biopsy.
Method:
- Enroll patients who continue to bleed despite conservative treatment for track bleeding that has occurred after liver biopsy.
- Radiofreqeuncy ablation: Under monitoring vital signs and controlling pain with intravenous agents, the electrode is inserted into the bleeding focus. The bleeding focus is ablated.
- Hemostasis is evaluated by ultrasound (right after radiofrequency ablation), CT scan (after the radiofrequency ablation), and ultrasound (the day after radiofrequency ablation)
- If hemostasis fails using radiofrequency ablation, transarterial hepatic embolization is performed immediately.
- Conditions
- Bleeding
- Being tested
- radiofrequency ablation
- Keywords
- liver, track bleeding, radiofrequency ablation
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequency ablationProcedure or surgery
Under the ultrasound guidance, the electrode is inserted into the bleeding focus of the liver and the bleeding focus is ablated.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency ablation group | Experimental | hemostasis using radiofrequency ablation for track bleeding Receives: Procedure: radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemostasis rate
success rate of hemostasis using radiofrequency ablation on CT taken after radiofrequency ablation
Measured: immediately after radiofrequency ablation
Secondary outcomes (1)
complication rate
complication rate associated with radiofrequency ablation on CT taken after radiofrequency ablation
Measured: immediately after radiofrequency ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start1 Jul 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyoung Doo Song
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kyoung Doo Song, Samsung Medical Center
- Investigators
- Kyoung Doo Song, Professor, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017350
- Sponsor's protocol ID
- 2021-04-028-003
- Status last verified
- Aug 2021
- First submitted
- 3 Aug 2021
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemostasis Using Radiofrequency Ablation for Track Bleeding After Liver Biopsy
- ClinicalTrials.gov ID
- NCT05017350
- Acronym / sponsor ID
- 2021-04-028-003
- Conditions
- Bleeding
- Keywords
- liver, track bleeding, radiofrequency ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Kyoung Doo SongUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 23 Aug 2021 (actual)
- 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.
This study aims to evaluate the usefulness of hemostasis using radiofrequency ablation for track bleeding that has occurred after percutaneous biopsy of the liver.
Detailed description
Purpose: To evaluate the usefulness of hemostasis using radiofrequency ablation for track bleeding after percutaneous liver biopsy.
Method:
- Enroll patients who continue to bleed despite conservative treatment for track bleeding that has occurred after liver biopsy.
- Radiofreqeuncy ablation: Under monitoring vital signs and controlling pain with intravenous agents, the electrode is inserted into the bleeding focus. The bleeding focus is ablated.
- Hemostasis is evaluated by ultrasound (right after radiofrequency ablation), CT scan (after the radiofrequency ablation), and ultrasound (the day after radiofrequency ablation)
- If hemostasis fails using radiofrequency ablation, transarterial hepatic embolization is performed immediately.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency ablation group | Experimental | Procedure: radiofrequency ablationhemostasis using radiofrequency ablation for track bleeding |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ultrasound guided percutaneous liver biopsy at Samsung Medical Center
- Track bleeding after biopsy
- Persistent track bleeding even after conservative management
- Consent to this study
Key exclusion criteria (5 listed)
- Not consent to this study
- <20 years old or >=80 years old
- Contraindication to radiofrequency ablation
- Radiofrequency ablation for track bleeding is not technically possible.
- Unstable vital signs
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 |
|---|---|---|
| radiofrequency ablationUnder the ultrasound guidance, the electrode is inserted into the bleeding focus of the liver and the bleeding focus is ablated. | Procedure or surgery | Radiofrequency ablation group |
Primary outcome
hemostasis rate
Time frame: immediately after radiofrequency ablation
success rate of hemostasis using radiofrequency ablation on CT taken after radiofrequency ablation
1 secondary outcome
complication rate
Time frame: immediately after radiofrequency ablation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Min Woo Lee, Professor contact
Kyoung Doo Song, Professor principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiofrequency ablation in people with Bleeding, run by Kyoung Doo Song at 1 site in South Korea.
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 4 inclusion and 5 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 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 Kyoung Doo Song, Professor (82-2-3410-2518, kd3893.song@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemostasis rate (time frame: immediately after radiofrequency ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Aug 2021.