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Status unknownNCT05818176Updated Apr 18, 2023

To Improve the Clinical Outcome of Ultrasound-guided Radiofrequency Ablation by NAVIRFA® Navigation System.

An interventional study of NAVIRFA® Navigation System and ultrasound in Radiofrequency Ablation, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-04-18.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Radiofrequency Ablation
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In context

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Patients with abnormal coagulation function and low platelets are not suitable for ablation therapy after evaluation by the trial host.
  2. 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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    NAVIRFA® Navigation System

    Device: NAVIRFA® Navigation System

  • Active comparator
    ultrasound-guided

    Device: ultrasound

Interventions

  • DeviceNAVIRFA® Navigation System

    radiofrequency ablation by NAVIRFA® Navigation System.

  • Deviceultrasound

    radiofrequency ablation by ultrasound

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What researchers measure

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).

    Time frame: Before ablation treatment

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Study locations

1 of 1 sites recruiting
  • National Taiwan University Hospital
    Taipei, Taiwan, Taiwan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05818176
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Apr 18, 2023
Start date
Apr 1, 2023
Primary completion
Jun 30, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Apr 18, 2023

Study contacts

Kai-Wen Huang, MD, PhD
Contact
fangyu0429@gmail.com
+886-23123456 ext. 265915

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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