18 and older, any sex, with Carcinoma, Hepatocellular or Liver Metastases. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Acute Technical Performance of the VORTX Rx® Medical Device for the Ablation of Primary and Metastatic Liver TumorsPrimary· 1-day post ablation
Number of Lesions that were Successfully Ablated according to technical success definition established in the protocol.
Group
Value
95% CI
VORTX Rx Treatment
11
Safety Profile of the VORTX Rx. Incidence of Adverse Events (Serious and Non-serious) That Are Probably or Definitely Device-relatedSecondary· 2 months
Number of Adverse Events (Serious and Non-serious) That Are Probably or Definitely Device-related
Group
Value
95% CI
VORTX Rx Treatment
0
Local Tumor ProgressionSecondary· 1 week, 1 month and 2 months post-procedure.
Number of patients who have indicated local tumor progression in at least one visit (1 week, 1 month, 2 months) for each tumor ablated.
The ablation zone will be assessed post-procedurally to evaluate local tumor progression by contrast-enhanced MRI imaging
Group
Value
95% CI
VORTX Rx Treatment
2
VORTX Rx Treatment
5
VORTX Rx Treatment
1
Involution of the Ablation ZoneSecondary· 24hours, 1 week, 1 month and 2 months, post-procedure.
The involution of the ablation zone will be assessed post-procedurally by contrast-enhanced MRI imaging at 24h, 1 week, 1 month and 2 months
Ablation zone volume (cm3): 24 hours
Group
Value
95% CI
VORTX Rx Treatment
10.5500
± 6.34405
Ablation zone volume (cm3): 1 week
Group
Value
95% CI
VORTX Rx Treatment
8.5000
± 9.56682
Ablation zone volume (cm3): 1 month
Group
Value
95% CI
VORTX Rx Treatment
5.9383
± 10.02174
Ablation zone volume (cm3): 2 months
Group
Value
95% CI
VORTX Rx Treatment
4.7683
± 9.47795
Assessment of Liver panel_Part 1Secondary· Screening, 24 hours, 1 week, 1 month and 2 months.
Liver panel will be evaluated on the basis of the change of aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase, gamma glutamyl transpeptidase (GGT) from baseline to evaluation visits 24 hours, 1 week and 1 and 2 months post procedure.
AST Screening
Group
Value
95% CI
VORTX Rx Treatment
60.7500
± 33.83662
AST 24 hours
Group
Value
95% CI
VORTX Rx Treatment
183.5000
± 80.71555
AST 1 week
Group
Value
95% CI
VORTX Rx Treatment
47.0000
± 25.17936
AST 1 month
Group
Value
95% CI
VORTX Rx Treatment
40.7500
± 10.68878
AST 2 months
Group
Value
95% CI
VORTX Rx Treatment
40.5000
± 19.94158
ALT Screening
Group
Value
95% CI
VORTX Rx Treatment
44.0000
± 22.13594
ALT 24 hours
Group
Value
95% CI
VORTX Rx Treatment
139.0000
± 56.12486
ALT 1 week
Group
Value
95% CI
VORTX Rx Treatment
58.5000
± 30.27100
Assessment of Liver Panel_Part 2Secondary· 24 hours, 1 week and 1 month and 2 months
Liver panel will be evaluated on the basis of the change of albumin from baseline to evaluation visits 24 hours, 1 week and 1 and 2 months post procedure.
Albumin Screening
Group
Value
95% CI
VORTX Rx Treatment
40.0250
± 2.88603
Albumin 24 hours
Group
Value
95% CI
VORTX Rx Treatment
34.7500
± 1.13284
Albumin 1 week
Group
Value
95% CI
VORTX Rx Treatment
37.5250
± 1.95683
Albumin 1 month
Group
Value
95% CI
VORTX Rx Treatment
39.3750
± 0.63966
Albumin 2 months
Group
Value
95% CI
VORTX Rx Treatment
40.1750
± 1.65806
Assessment of Liver Panel_Part 3Secondary· 24 hours, 1 week and 1month and 2 months
Liver panel will be evaluated on the basis of the change of bilirubin from baseline to evaluation visits 24 hours, 1 week and 1 and 2 months post procedure
Total Bilirrubin Screening
Group
Value
95% CI
VORTX Rx Treatment
0.7525
± 0.42578
Total Bilirrubin 24 hours
Group
Value
95% CI
VORTX Rx Treatment
0.6425
± 0.20549
Total Bilirrubin 1 week
Group
Value
95% CI
VORTX Rx Treatment
0.7600
± 0.32934
Total Bilirrubin 1 month
Group
Value
95% CI
VORTX Rx Treatment
0.5250
± 0.11561
Total Bilirrubin 2 months
Group
Value
95% CI
VORTX Rx Treatment
0.7050
± 0.31268
Assessment of Liver Panel_part 4Secondary· 24 hours, 1 week and 1month and 2 months
Liver panel will be evaluated on the basis of the change of prothrombin time (PT) from baseline to evaluation visits 24 hours, 1 week and 1 and 2 months post procedure
Prothrombin time Screening
Group
Value
95% CI
VORTX Rx Treatment
95.2500
± 5.50000
Prothrombin time 24 hours
Group
Value
95% CI
VORTX Rx Treatment
92.5000
± 9.94987
Prothrombin time 1 week
Group
Value
95% CI
VORTX Rx Treatment
92.7500
± 8.38153
Prothrombin time 1 month
Group
Value
95% CI
VORTX Rx Treatment
98.7500
± 2.50000
Prothrombin time 2 months
Group
Value
95% CI
VORTX Rx Treatment
91.2500
± 17.50000
Assessment of Liver Panel_Part 5Secondary· 24 hours, 1 week and 1 month and 2 months
Liver panel will be evaluated on the basis of the change of International normalized ratio (INR = A system established by the World Health Organization (WHO) and the International Committee on Thrombosis and Hemostasis for reporting the results of blood coagulation (clotting) tests) from baseline to evaluation visits 24 hours, 1 week and 1 and 2 months post procedure.
The INR is derived from prothrombin time (PT) which is calculated as a ratio of the patient's PT to a control PT standardized for the potency of the thromboplastin reagent developed by the World Health Organization (WHO) using t
INR Screening
Group
Value
95% CI
VORTX Rx Treatment
1.0500
± 0.5774
INR 24 hours
Group
Value
95% CI
VORTX Rx Treatment
1.0750
± 0.09574
INR 1 week
Group
Value
95% CI
VORTX Rx Treatment
1.0500
± 0.05774
INR 1 month
Group
Value
95% CI
VORTX Rx Treatment
1.0250
± 0.05000
INR 2 months
Group
Value
95% CI
VORTX Rx Treatment
1.0750
± 0.15000
Immunologic Assessment_Part 1Secondary· Baseline/Screening, 1-day post ablation, 1 week and 1 and 2 months post procedure
Immunological response of ablation will be evaluated on the basis of immune tests conducted and tumor biomarker assessments (including, but not limited to, immune tests: CD3+, CD4+, CD8+, CD45+, CD16+, CD56+ and CD19+ from Baseline/Screening to 1-day post ablation, 1 week and 1 and 2 months post procedureprocedure.
CD3+ (T cells) Screening
Group
Value
95% CI
VORTX Rx Treatment
801.7500
± 374.33708
CD3+ (T cells) 24 hours
Group
Value
95% CI
VORTX Rx Treatment
618.2500
± 365.48814
CD3+ (T cells) 1 week
Group
Value
95% CI
VORTX Rx Treatment
713.7500
± 234.09596
CD3+ (T cells) 1 month
Group
Value
95% CI
VORTX Rx Treatment
587.7500
± 253.11575
CD3+ (T cells) 2 months
Group
Value
95% CI
VORTX Rx Treatment
632.0000
± 150.53017
CD4+ (T helper cells) Screening
Group
Value
95% CI
VORTX Rx Treatment
469.2500
± 146.20619
CD4+ (T helper cells) 24 hours
Group
Value
95% CI
VORTX Rx Treatment
374.7500
± 128.99709
CD4+ (T helper cells) 1 week
Group
Value
95% CI
VORTX Rx Treatment
445.2500
± 121.94637
Immunologic Assessment_Part 2Secondary· Screening, 24 hours, 1 week and 1 and 2 months post procedure.
Immunological response of ablation will be evaluated on the basis of immune tests conducted and tumor biomarker assessments: C-reactive protein \[CRP\], from baseline to evaluation visits 1 day, 1 week and 1 and 2 months post procedure.
C reactive protein Screening
Group
Value
95% CI
VORTX Rx Treatment
5.9750
± 5.67355
C reactive protein 24 hours
Group
Value
95% CI
VORTX Rx Treatment
6.0250
± 7.06323
C reactive protein 1 week
Group
Value
95% CI
VORTX Rx Treatment
30.8250
± 53.05735
C reactive protein 1 month
Group
Value
95% CI
VORTX Rx Treatment
4.7750
± 3.57713
C reactive protein 2 months
Group
Value
95% CI
VORTX Rx Treatment
11.9500
± 8.85795
Immunologic Assessment_Part 3Secondary· Screening, 24 hours post ablation, 1 week and 1 and 2 months post procedure.
Immunological response of ablation will be evaluated on the basis of immune tests conducted and tumor biomarker assessments (including, but not limited to, immune tests): complement C3 and C4, immunoglobulins \[IgG, IgM, IgA\] from baseline to evaluation visits 1 day, 1 week and 1 and 2 months post procedure.
Complement C3 Screening
Group
Value
95% CI
VORTX Rx Treatment
144.0000
± 53.61592
Complement C3 24 hours
Group
Value
95% CI
VORTX Rx Treatment
123.2000
± 25.76354
Complement C3 1 week
Group
Value
95% CI
VORTX Rx Treatment
150.5000
± 22.75229
Complement C3 1 month
Group
Value
95% CI
VORTX Rx Treatment
143.9000
± 44.60239
Complement C3 2 months
Group
Value
95% CI
VORTX Rx Treatment
134.7500
± 26.88711
Complement C4 Screening
Group
Value
95% CI
VORTX Rx Treatment
30.7750
± 20.29949
Complement C4 24 hours
Group
Value
95% CI
VORTX Rx Treatment
23.7750
± 6.58401
Complement C4 1 week
Group
Value
95% CI
VORTX Rx Treatment
29.8250
± 9.00717
Adverse events — posted to ClinicalTrials.gov
Time frame: 2 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
VORTX Rx Treatment
Serious: 2/8 (25%)
Deaths: 0/8
Serious adverse events (2 terms)
Reaction
System
VORTX Rx Treatment
FEVER
General disorders
—
HYPOCALCEMIA
Metabolism and nutrition disorders
—
Other adverse events (34 terms — click to expand)
Reaction
System
VORTX Rx Treatment
ALT increase
Hepatobiliary disorders
—
AST increase
Hepatobiliary disorders
—
Fatigue
General disorders
—
Sciatic pain
Nervous system disorders
—
Anorexia
Metabolism and nutrition disorders
—
Constipation
Gastrointestinal disorders
—
GGT increase
Hepatobiliary disorders
—
Nausea
Gastrointestinal disorders
—
Transaminase elevation
Hepatobiliary disorders
—
Abdominal discomfort
General disorders
—
Abdominal pain
General disorders
—
Adverse reaction to analeptics and opioid receptor antagonists
Multi-center, Open-labeled, Non-randomized Study to Evaluate the Acute Technical Performance and Safety Profile of the VORTX Rx® for Ablation of Primary and Metastatic Liver Tumors
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by HistoSonics, Inc.
Last refreshed: 20 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03741088.