Clinical trial · Interventional
Histotripsy (HistoSonics®) for Liver Tumours
Histotripsy (HistoSonics®) for Liver Tumours: a Phase II Safety and Efficacy Study
- 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)
Histotripsy is a promising non-invasive technique that uses high-intensity ultrasound waves to disrupt tissue without damaging surrounding structures. It works by using high-intensity ultrasound waves to create microscopic bubbles within the tumour tissue. These bubbles rapidly expand and collapse, generating shock waves that disrupt the tissue. The technique is highly precise and can be targeted to specific areas of the liver, allowing for selective destruction of tumour cells while minimizing damage to healthy tissue. This study will enrol 20 patients with liver tumours (be it primary or secondary liver tumours), monitor their post-operative adverse events, and study the changes in tumour size and volume after treatment. Histotripsy will be performed under general anaesthesia, with real-time monitoring by ultrasound, and deliver high-intensity ultrasound waves in single session or multiple sessions. Similar to other minimal invasive treatments, patients will be admitted 1 day prior, then receive Histotripsy on the next day and stay overnight for observation. Patients will be discharged on the 3rd day if unremarkable. During the hospital stay, blood samplings will be taken for evaluation around 2-4 times in total depending on the length of hospital stay.
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 Tumour | Liver Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Histotripsy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Histotripsy
- description
- Histotripsy is a promising non-invasive technique that uses high-intensity ultrasound waves to disrupt tissue without damaging surrounding structures
- interventionNames
- Radiation: Histotripsy
Primary outcomes (2)
- measure
- Changes in tumour features
- timeFrame
- up to 36 months
- description
- Changes in tumour size and volume before and after intervention
- measure
- Post procedure adverse events and complication
- timeFrame
- The whole duration of hospital stay, normally 3 days on average
- description
- Post procedure adverse events and complication
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Fit for general anaesthesia * Liver tumour size \< 10cm * Solitary or multifocal * Primary liver tumour such as hepatocellular carcinoma or intrahepatic cholangiocarcinoma * Secondary liver tumour such as liver metastasis * Patients with operable or inoperable liver tumours * Liver transplant candidates awaiting for liver graft Exclusion Criteria: * Refusal to take part in clinical trial * Child C liver cirrhosis * Not fit for general anaesthesia
References
Publications (0)
Data not yet available