NCT05017350

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 3, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 23, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

August 23, 2021

Status Verified

August 1, 2021

Enrollment Period

3.5 years

First QC Date

August 3, 2021

Last Update Submit

August 17, 2021

Conditions

Bleeding

Keywords

livertrack bleedingradiofrequency ablation

Outcome Measures

Primary Outcomes (1)

  • hemostasis rate

    success rate of hemostasis using radiofrequency ablation on CT taken after radiofrequency ablation

    immediately after radiofrequency ablation

Secondary Outcomes (1)

  • complication rate

    immediately after radiofrequency ablation

Study Arms (1)

Radiofrequency ablation group

EXPERIMENTAL

hemostasis using radiofrequency ablation for track bleeding

Procedure: radiofrequency ablation

Interventions

radiofrequency ablationPROCEDURE

Under the ultrasound guidance, the electrode is inserted into the bleeding focus of the liver and the bleeding focus is ablated.

Radiofrequency ablation group

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ultrasound guided percutaneous liver biopsy at Samsung Medical Center
  • Track bleeding after biopsy
  • Persistent track bleeding even after conservative management
  • Consent to this study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Hemorrhage

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Kyoung Doo Song, Professor

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyoung Doo Song, Professor

CONTACT

82-2-3410-2518kd3893.song@samsung.com

Min Woo Lee, Professor

CONTACT

mw2542.lee@samsung.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 3, 2021

First Posted

August 23, 2021

Study Start

July 1, 2021

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

August 23, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)