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

NCT ID: NCT05818176

Last Updated: 2023-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Radiofrequency Ablation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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NAVIRFA® Navigation System

Group Type EXPERIMENTAL

NAVIRFA® Navigation System

Intervention Type DEVICE

radiofrequency ablation by NAVIRFA® Navigation System.

ultrasound-guided

Group Type ACTIVE_COMPARATOR

ultrasound

Intervention Type DEVICE

radiofrequency ablation by ultrasound

Interventions

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NAVIRFA® Navigation System

radiofrequency ablation by NAVIRFA® Navigation System.

Intervention Type DEVICE

ultrasound

radiofrequency ablation by ultrasound

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hospital

Taipei, Taiwan, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Kai-Wen Huang, MD, PhD

Role: CONTACT

+886-23123456 ext. 265915

Facility Contacts

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Kai-Wen Huang

Role: primary

Other Identifiers

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202211106DIPB

Identifier Type: -

Identifier Source: org_study_id

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