A Study of the Safety and Effectiveness of a Compound Steep-Pulse Therapy Apparatus for Malignant Liver Tumors
NCT07916350, Not applicable, Completed, REMD Medical Technology
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Study of the Safety and Effectiveness of a Compound Steep-Pulse Therapy Apparatus for Malignant Liver Tumors | ClinicalTrials.gov |
| NCT number | NCT07916350 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 181 participants, actual | ClinicalTrials.gov |
| Lead sponsor | REMD Medical Technology | ClinicalTrials.gov |
| Conditions | Malignant Liver Tumors | ClinicalTrials.gov |
| Interventions | Compound Steep-Pulse Therapy Apparatus (HFMP-02), Cool-tip RF Ablation System (CTRF220) | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Ablation success rate at 1 month after ablation | 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%. | ClinicalTrials.gov |
| Secondary | Ablation success rate at 3 months after ablation | 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% | ClinicalTrials.gov |
| Secondary | Complete ablation rate | At 1 month and 3 months after ablation | number of target lesions with complete ablation in the group / total number of target lesions in the group × 100% | ClinicalTrials.gov |
| Secondary | Disease control rate | At 3 months after ablation | 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. | ClinicalTrials.gov |
| Secondary | Objective response rate | at 3 months after ablation | Objective response rate (ORR) = number of subjects in the group with (CR + PR) / number of subjects in the group × 100% | ClinicalTrials.gov |
| Secondary | Complete response rate | at 3 months after ablation | Complete response rate (CR) = number of subjects in the group with CR / number of subjects in the group × 100%. | ClinicalTrials.gov |
| Secondary | Local recurrence-free rate | at 1 month and 3 months after ablation | Recurrence-free rate = number of recurrence-free cases / total number of treated cases × 100%. | ClinicalTrials.gov |
| Secondary | Incidence of procedure-related complications | From the ablation procedure through 6 months after ablation | number of cases with the complication / total number of cases × 100% | ClinicalTrials.gov |
| Secondary | Console operability | During the ablation procedure (Day 0) | 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. | ClinicalTrials.gov |
| Secondary | System stability | During the ablation procedure (Day 0) | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)