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

National Taiwan University

Status: Enrolling

Conditions: Radiofrequency Ablation

Treatments: Device: ultrasound; Device: NAVIRFA® Navigation System

Study type: Interventional

Funder types: Other

Identifiers

NCT05818176

202211106DIPB

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

NAVIRFA® Navigation System

Experimental group

Treatment:

Device: NAVIRFA® Navigation System

ultrasound-guided

Active Comparator group

Treatment:

Device: ultrasound