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

April 5, 2023 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ultrasound-guided
Device: ultrasound
radiofrequency ablation by ultrasound
Experimental: NAVIRFA® Navigation System
Device: NAVIRFA® Navigation System
radiofrequency ablation by NAVIRFA® Navigation System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
required scan time
Time Frame: 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).
Before ablation treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

April 5, 2023

First Submitted That Met QC Criteria

April 5, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 5, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 202211106DIPB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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