Clinical trial · Interventional
Multicentre Prospective Clinical Trial for RFA Tumour Aspirator Treatment of Primary and Secondary Malignancies of the Liver
A Multicentre Prospective Clinical Trial of a New Bipolar Radiofrequency Ablation/Aspirator Device (Hexablate) in the Management of Primary and Secondary Liver Cancers
NCT00514930CI-TRIAL-00000831unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary aim for this trial is to assess whether the RFA aspirator device is safe and of clinical benefit in patients with primary or secondary malignant liver tumours
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hexablate | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To estimate the local and remote intra-hepatic and extra-hepatic recurrence rates and their impact on survival.
- timeFrame
- 2 years
Secondary outcomes (1)
- measure
- Complications and unexpected adverse events (early and late) related to RFA aspirator treatment to be assessed. Data points to be collected as per proforma for trial.
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Eligible participants will be 18 years and older. * Have unresectable primary/secondary malignant tumours of the liver. Unresectable criteria being the presence of extra-hepatic disease, limited liver synthetic function, co-morbidity (ASA 3), bilobar disease and anatomical location. * Study specific signed informed consent will also have to be completed to allow patient inclusion. Exclusion Criteria: * Age younger than 18 years old * Pregnant women * Uncorrectable coagulopathy
References
Publications (1)
- DERIVEDZacharoulis D, Khorsandi SE, Vavra P, Dostalik J, Navarra G, Nicholls JP, Jiao LR, Habib NA. Pilot study for a new bipolar radiofrequency ablation/aspirator device in the management of primary and secondary liver cancers. Liver Int. 2009 Jul;29(6):824-30. doi: 10.1111/j.1478-3231.2008.01910.x. PMID 19638109