NCT05818176

Brief Summary

Ultrasonic-guided radiofrequency ablation is the most common minimally invasive treatment for liver cancer. This study will use my country's self-developed intelligent ultrasonic navigation tool (NAVIRFA® Navigation System) to assist in the puncture of the needle during ablation, to observe the operation time, Whether the needle accuracy, ablation effect and complications are different from the traditional free-hand ultrasonic guidance technology.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 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

April 1, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

3 months

First QC Date

April 5, 2023

Last Update Submit

April 5, 2023

Conditions

Radiofrequency Ablation

Outcome Measures

Primary Outcomes (1)

  • required scan time

    the time required until start of the ablation (measured from the time of the first US scan to the start of the ablation).

    Before ablation treatment

Study Arms (2)

NAVIRFA® Navigation System

EXPERIMENTAL
Device: NAVIRFA® Navigation System

ultrasound-guided

ACTIVE COMPARATOR
Device: ultrasound

Interventions

NAVIRFA® Navigation SystemDEVICE

radiofrequency ablation by NAVIRFA® Navigation System.

NAVIRFA® Navigation System
ultrasoundDEVICE

radiofrequency ablation by ultrasound

ultrasound-guided

Eligibility Criteria

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

You may qualify if:

  • Patients with malignant liver tumors less than three centimeters in size who are expected to suffer radiofrequency tumor ablation in the hospital.
  • At least 20 years old.

You may not qualify if:

  • Patients with abnormal coagulation function and low platelets are not suitable for ablation therapy after evaluation by the trial host.
  • Those who are unable to accept computerized tomography and MRI examinations, such as poor renal function or contrast agent allergy, are not suitable for examination after the evaluation of the test host.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

RECRUITING

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Kai-Wen Huang, MD, PhD

CONTACT

+886-23123456fangyu0429@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2023

First Posted

April 18, 2023

Study Start

April 1, 2023

Primary Completion

June 30, 2023

Study Completion

December 31, 2023

Last Updated

April 18, 2023

Record last verified: 2023-04

Locations

TW(1)