Sound waves vs. tumors: new device aims to zap pain without surgery
NCT ID NCT07180706
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests a device called histotripsy, which uses focused ultrasound to break up tumors without cutting the skin. It is for people with abdominal tumors that cannot be surgically removed and are causing symptoms like pain. The goal is to see if the treatment improves quality of life and reduces pain, while monitoring safety. The trial will enroll 30 participants at a single hospital in Taiwan.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Histotripsy (non-invasive focused ultrasound device)
- What this could lead to
- If successful, this could offer a needle-free, non-invasive option to shrink tumors and ease pain or discomfort for people with inoperable abdominal tumors.
- What could go wrong
- This is a small, early-stage study (30 people) with no control group. The device is not yet approved in Taiwan, and long-term benefits or risks are still unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2025
An estimate. Start dates often move.
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Ages Eligible for Study: 18 Years and older * Diagnosed with a malignant liver tumor at National Taiwan University Hospital. - participants with intra-abdominal tumors measuring between 3 to 10 cm in diameter, such as hepatobiliary or pancreatic cancer, benign or malignant retroperitoneal tumors, or malignant sarcomas, who are experiencing tumor-related symptoms and discomfort. * unresectable areas due to the presence of distant metastases, invasion of blood vessels or vital organs, or the risk of organ dysfunction resulting from tumor resection. * participants with good physical condition, having an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1, and an American Society of Anesthesiologists (ASA) score of less than 3. * No severe hepatic or renal dysfunction (Child-Pugh class A/B); total serum bilirubin ≤ 5 mg/dL; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within five times the upper limit of normal; serum creatinine within two times the upper limit of normal. * Normal coagulation function, with a prothrombin time international normalized ratio (PT-INR) ≤ 2.0 and a platelet count above 100,000. * Estimated life expectancy of more than three months. * The maximum depth from the tumor to the skin surface is within 14 cm. Exclusion Criteria: * Tumors that cannot be clearly localized by ultrasound. * Inability to find a safe internal path for ultrasound to reach the tumor during imaging evaluation, such as the presence of unsuitable media for ultrasound propagation like skin scars, intestinal gas, calcified tumors, and bones in the path. * Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception, * Received treatment with an investigational agent/ procedure within 30 days prior to Histotripsy treatment * Have undergone radiation therapy in the focused ultrasound treatment area within 30 days before or after treatment. * arterial calcification in the ultrasound treatment area. * Investigator-assessed contraindications * Inability to undergo CT/MRI imaging * Known history of HIV infection * Tumor not clearly visualized on ultrasound * No safe ultrasound pathway due to scarring, bowel gas, calcified tumor, or bone interference * Prior radiotherapy within 30 days before or after treatment * Arterial calcification in the treatment area * arterial calcification in the ultrasound treatment area. * Severe anesthesia intolerance * Tumor invasion of major vessels, gastrointestinal tract, or respiratory tract * within systemic infections; tissue ablation is not suitable until the infection is controlled. * Other contraindications related to the medical device in this trial: 1. Poor tolerance to anesthetics. 2. The target tumor is less than 1 cm from the skin. 3. within severe organ dysfunction, such as heart, liver, kidney, brain, or lung. 4. within severe cachexia, extreme fatigue, or severe ascites. 5. within severe diabetes. 6. The treatment target involves important blood vessels or portal vein thrombosis, or the tumor has invaded the vessel wall or significantly compressed blood vessels. 7. The tumor has invaded the digestive tract or respiratory tract.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Taiwan University Hospital
Taipei, 100, Taiwan
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