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Malignant Liver TumorsNCT07916350

A Study of the Safety and Effectiveness of a Compound Steep-Pulse Therapy Apparatus for Malignant Liver Tumors

A study testing Compound Steep-Pulse Therapy Apparatus (HFMP-02) and Cool-tip RF Ablation System (CTRF220) in people with Malignant Liver Tumors, run by REMD Medical Technology at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This prospective, multicenter, randomized, parallel-group, open-label, noninferiority study compares the safety and efficacy of the Compound Steep-Pulse Therapy Apparatus with radiofrequency ablation in adults with malignant liver tumors. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Malignant Liver Tumors
What is being tested?
Compound Steep-Pulse Therapy Apparatus (HFMP-02) and Cool-tip RF Ablation System (CTRF220)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
181 participants
Where
1 siteChina
Study dates
28 Dec 2021to 6 Dec 2024
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1.Age ≥18 and ≤80 years, regardless of sex.
  • 2.Diagnosed with a malignant liver tumor.
  • 3.Child-Pugh class A or B liver function.
  • 4.A single tumor ≤4 cm in diameter, or up to three tumor lesions, each with a maximum diameter ≤3 cm.
  • 5.Willing to participate in the study and voluntarily provide written informed consent.
  • 6.Expected survival >6 months.

Who cannot join

  • 1.Severe dysfunction of major organs, such as the heart, lungs, or kidneys, that, in the investigator's judgment, would preclude tolerance of treatment.
  • 2.Contraindications to general anesthesia.
  • 3.Allergy to contrast agents used for CT or MRI.
  • 4.Previous ablation of the target lesion. Newly developed lesions adjacent to a previously ablated target lesion may be eligible.
  • 5.Imaging evidence of invasion of major blood vessels or bile ducts on liver CT, MRI, or other imaging examinations.
  • 6.Severe coagulation abnormalities, defined as a platelet count <50 × 10⁹/L or prolongation of prothrombin time by >5 seconds.
Show all 14Show fewer
  • 7.Uncorrectable refractory massive ascites or cachexia.
  • 8.Severe portal hypertension or a history of esophageal variceal bleeding within the past month.
  • 9.An implanted cardiac pacemaker or a metallic implant within 2.5 cm of the ablation zone.
  • 10.A history of epilepsy.
  • 11.A history of severe arrhythmia within the past month that could not be controlled with medication.
  • 12.Pregnancy, breastfeeding, or plans to conceive during the study.
  • 13.Participation in another drug or medical device trial without having exited that trial before enrollment.
  • 14.Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Nortion Medical Technology Co., Ltd

    Shanghai, Shanghai Municipality, 201318

Other trials in China

About this study

Official title: A Prospective, Parallel-Group, Randomized, Controlled, Noninferiority, Multicenter Study Evaluating the Safety and Efficacy of a Compound Steep-Pulse Therapy Apparatus for Malignant Liver Tumors

This prospective, multicenter, randomized, parallel-group, open-label, noninferiority study compares the safety and efficacy of the Compound Steep-Pulse Therapy Apparatus with radiofrequency ablation in adults with malignant liver tumors. Eligible participants are randomly assigned in a 1:1 ratio to the test group or the control group using a web-based central randomization system, with stratification by tumor diameter and tumor type.

The primary outcome is the ablation success rate at 1 month after treatment, assessed by contrast-enhanced computed tomography or magnetic resonance imaging under blinded conditions. Secondary outcomes include ablation success at 3 months, complete ablation rates, tumor response, local recurrence-free rates, procedure-related complications, console operability, and system stability. Safety is evaluated through adverse events and laboratory assessments.

Being tested
Compound Steep-Pulse Therapy Apparatus (HFMP-02), Cool-tip RF Ablation System (CTRF220)
Keywords
IRE, malignant liver tumors, randomized

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Compound Steep-Pulse Therapy Apparatus (HFMP-02)Device

    The Compound Steep-Pulse Therapy Apparatus (Nortion, model HFMP-02) delivers microsecond-level, bipolar, high-intensity composite pulses to solid tumors to induce irreversible electroporation (IRE)-mediated cell death. In this trial it is used for local ablation of liver malignant tumors.

  • Cool-tip RF Ablation System (CTRF220)Device

    The Cool-tip RF Ablation System (Covidien/Medtronic, model CTRF220) is a radiofrequency ablation generator indicated for coagulation and ablation of tissue during percutaneous, laparoscopic, and surgical procedures. In this trial it serves as the active comparator for local ablation of liver malignant tumors.

Study groups in NCT07916350
Study groupRoleWhat they receive
High-Frequency Irreversible Electroporation (H-FIRE)ExperimentalPatients with liver malignant tumors in this arm receive local ablation using High-Frequency Irreversible Electroporation (H-FIRE) delivered by the Compound Steep-Pulse Therapy Apparatus (Nortion, model HFMP-02).
Receives: Device: Compound Steep-Pulse Therapy Apparatus (HFMP-02)
Radiofrequency Ablation (RFA)Active comparatorPatients with liver malignant tumors in this arm receive local ablation using Radiofrequency Ablation (RFA) delivered by the Cool-tip RF Ablation System (Covidien, model CTRF220).
Receives: Device: Cool-tip RF Ablation System (CTRF220)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ablation success rate at 1 month after ablation

    number of subjects in the group with complete ablation of the target lesion / total number of subjects in the group × 100%.

    Measured: 1 month after ablation

Secondary outcomes (9)

  1. Ablation success rate at 3 months after ablation

    number of subjects in the group with complete ablation of the target lesion / total number of subjects in the group × 100%

    Measured: at 3 months after ablation

  2. Complete ablation rate

    number of target lesions with complete ablation in the group / total number of target lesions in the group × 100%

    Measured: At 1 month and 3 months after ablation

  3. Disease control rate

    Disease control rate (DCR) = number of subjects in the group with (CR + PR + SD) / number of subjects in the group × 100%

    Assessment is performed using the mRECIST criteria:

    1. Complete response (CR): disappearance of any intratumoral arterial enhancement in all lesions.
    2. Partial response (PR): at least a 30% decrease in the sum of diameters of target lesions (with arterial-phase enhancement).
    3. Stable disease (SD): neither CR/PR nor PD.
    4. Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions (with arterial-phase enhancement), or appearance of new lesions.

    Measured: At 3 months after ablation

  4. Objective response rate

    Objective response rate (ORR) = number of subjects in the group with (CR + PR) / number of subjects in the group × 100%

    Measured: at 3 months after ablation

  5. Complete response rate

    Complete response rate (CR) = number of subjects in the group with CR / number of subjects in the group × 100%.

    Measured: at 3 months after ablation

  6. Local recurrence-free rate

    Recurrence-free rate = number of recurrence-free cases / total number of treated cases × 100%.

    Measured: at 1 month and 3 months after ablation

  7. Incidence of procedure-related complications

    number of cases with the complication / total number of cases × 100%

    Measured: From the ablation procedure through 6 months after ablation

  8. Console operability

    Rated on three levels:

    • Satisfactory: the interface is clear and easy to recognize, button and icon positions are reasonable, operating procedures are convenient, and parameter setting can be completed rapidly.
    • Acceptable: the interface is recognizable, button and icon positions are basically reasonable, operating procedures can be mastered through ordinary training, and parameter setting can be completed within an acceptable time.
    • Unsatisfactory: the interface is difficult to recognize, button and icon positions are disorganized, operating procedures are cumbersome, and parameter setting is difficult.

    Measured: During the ablation procedure (Day 0)

  9. System stability

    Instrument stability is rated on three levels:

    • Very stable: no instrument-related mechanical or electrical event occurred during the procedure and there was no adverse effect on the procedure.
    • Stable: minor instrument-related mechanical or electrical events occurred during the procedure but did not affect the procedure.
    • Unstable: frequent minor instrument-related mechanical or electrical events occurred during the procedure and affected the procedure.

    Measured: During the ablation procedure (Day 0)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2026
  2. Study start28 Dec 2021
  3. Primary completion26 Jun 2024
  4. Study completion6 Dec 2024

Resources

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
Outcomes assessor
Enrolment
181 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07916350
Sponsor's protocol ID
REMD03
Status last verified
Oct 2026
First submitted
23 Oct 2026
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared. The complete dataset contains sensitive clinical and imaging records, as well as device-specific proprietary parameters essential to the High-Frequency Irreversible Electroporation (H-FIRE) technology. Sharing these data externally poses significant risks to intellectual property protection. Furthermore, external sharing of de-identified IPD would require extensive compliance reviews to ensure adherence to patient privacy regulations and cross-border data security laws. Aggregate summary results will be reported in the primary publication.

Questions about this trial

What is this clinical trial studying?

A study testing Compound Steep-Pulse Therapy Apparatus (HFMP-02) and Cool-tip RF Ablation System (CTRF220) in people with Malignant Liver Tumors, run by REMD Medical Technology at 1 site in China.

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 6 inclusion and 14 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: finished, as of the sponsor's last update on 4 Nov 2026. 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 China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ablation success rate at 1 month after ablation (time frame: 1 month after ablation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07916350.

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 4 Nov 2026.

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