- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05818176
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
- Name: Kai-Wen Huang, MD, PhD
- Phone Number: 265915 +886-23123456
- Email: fangyu0429@gmail.com
Study Locations
-
-
-
Taipei, Taiwan, Taiwan
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Kai-Wen Huang
- Email: skywing@ntuh.gov.tw
-
-
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:
- Patients with malignant liver tumors less than three centimeters in size who are expected to suffer radiofrequency tumor ablation in the hospital.
- At least 20 years old.
Exclusion Criteria:
- Patients with abnormal coagulation function and low platelets are not suitable for ablation therapy after evaluation by the trial host.
- 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
|
radiofrequency ablation by ultrasound
|
Experimental: 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.
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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