Radiofrequency AblationNCT05818176
To Improve the Clinical Outcome of Ultrasound-guided Radiofrequency Ablation by NAVIRFA® Navigation System.
A study testing NAVIRFA® Navigation System and ultrasound in people with Radiofrequency Ablation, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Radiofrequency Ablation
- What is being tested?
- NAVIRFA® Navigation System and ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan
Kai-Wen Huang, skywing@ntuh.gov.tw
About this study
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.
- Conditions
- Radiofrequency Ablation
- Being tested
- NAVIRFA® Navigation System, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAVIRFA® Navigation SystemDevice
radiofrequency ablation by NAVIRFA® Navigation System.
ultrasoundDevice
radiofrequency ablation by ultrasound
| Study group | Role | What they receive |
|---|---|---|
| NAVIRFA® Navigation System | Experimental | Not described Receives: Device: NAVIRFA® Navigation System |
| ultrasound-guided | Active comparator | Not described Receives: Device: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
required scan time
the time required until start of the ablation (measured from the time of the first US scan to the start of the ablation).
Measured: Before ablation treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Apr 2023
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiofrequency AblationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818176
- Sponsor's protocol ID
- 202211106DIPB
- Status last verified
- Apr 2023
- First submitted
- 5 Apr 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Improve the Clinical Outcome of Ultrasound-guided Radiofrequency Ablation by NAVIRFA® Navigation System.
- ClinicalTrials.gov ID
- NCT05818176
- Acronym / sponsor ID
- 202211106DIPB
- Conditions
- Radiofrequency Ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAVIRFA® Navigation System | Experimental | Device: NAVIRFA® Navigation System |
| ultrasound-guided | Active comparator | Device: ultrasound |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NAVIRFA® Navigation Systemradiofrequency ablation by NAVIRFA® Navigation System. | Device | NAVIRFA® Navigation System |
| ultrasoundradiofrequency ablation by ultrasound | Device | ultrasound-guided |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NAVIRFA® Navigation System and ultrasound in people with Radiofrequency Ablation, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai-Wen Huang, MD, PhD (+886-23123456 ext. 265915, fangyu0429@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
required scan time (time frame: Before ablation treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.