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

Radiofrequency Ablation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05818176
• Other study ID #: 202211106DIPB
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: National Taiwan University Hospital
• Contact: Kai-Wen Huang, MD, PhD
• Phone: +886-23123456
• Email: fangyu0429[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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:

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.

Related Conditions & MeSH terms

• Radiofrequency Ablation

Intervention

Device:
• NAVIRFA® Navigation System
radiofrequency ablation by NAVIRFA® Navigation System.
• ultrasound
radiofrequency ablation by ultrasound

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei, Taiwan

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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