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

Not Applicable

Recruiting

• Conditions: Radiofrequency Ablation
• Interventions: Device: NAVIRFA® Navigation System; Device: ultrasound

• Registration Number: NCT05818176
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-04
• Study Start: 2023-04-01
• Study First Submitted: 2023-04-05
• Study First Submitted QC: 2023-04-05
• Last Update Submitted: 2023-04-05
• Study First Posted: 2023-04-18
• Last Update Posted: 2023-04-18
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NAVIRFA® Navigation System	NAVIRFA® Navigation System	-
ultrasound-guided	ultrasound	-

Primary Outcome Measures

Name	Time	Method
required scan time	Before ablation treatment	the time required until start of the ablation (measured from the time of the first US scan to the start of the ablation).

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan, Taiwan