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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05818176
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
9
Anticipated Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: NAVIRFA® Navigation System
  • Device: ultrasound
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
To Improve the Clinical Outcome of Ultrasound-guided Radiofrequency Ablation by NAVIRFA® Navigation System.
Actual Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: NAVIRFA® Navigation System

Device: NAVIRFA® Navigation System
radiofrequency ablation by NAVIRFA® Navigation System.
Active Comparator: ultrasound-guided

Device: ultrasound
radiofrequency ablation by ultrasound

Outcome Measures

Primary Outcome Measures

  1. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University Hospital Taipei, Taiwan Taiwan

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT05818176
Other Study ID Numbers:
  • 202211106DIPB
First Posted:
Apr 18, 2023
Last Update Posted:
Apr 18, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 18, 2023