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OpenTrials
Active, Not Recruiting

NCT Number: NCT06579833

Histotripsy (HistoSonics®) for Liver Tumours

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Hong Kong

Hong Kong, 0000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Histotripsy

Radiation

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.

Other names: HistoSonics

Primary outcomes

  1. Changes in tumour features

    Time frame: up to 36 months

    Changes in tumour size and volume before and after intervention

  2. Post procedure adverse events and complication

    Time frame: The whole duration of hospital stay, normally 3 days on average

    Post procedure adverse events and complication

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Histotripsy (HistoSonics®) for Liver Tumours: a Phase II Safety and Efficacy Study

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Aug 30, 2024
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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