NCT07470008

Prospective Registry of Histotripsy for Soft Tissue Tumors

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Histotripsy is a treatment that uses focused ultrasound waves to break down tissue without surgery. The ultrasound waves meet at a specific spot and turn the tissue into liquid. This study is a prospective observational registry of participants receiving histotripsy. The goal of this study is to gather information about the use of histotripsy to confirm it is safe and effective medical procedure.

Detailed description

PRIMARY OBJECTIVES: 1. Tumor response on imaging will be assessed using standardized criteria for tumor types such as European Association for the Study of the Liver (EASL), Response Evaluation Criteria in Solid Tumors (RECIST), and modified RECIST (mRECIST). 2. Progression free survival and overall survival. 3. Risk factors for adverse events identified by NCI Common Terminology Criteria for Adverse Events (CTCAE). OUTLINE: Researchers will collect data from participants' regular doctor visits via medical records for three years after the Histotripsy procedure has taken place.

Conditions

• Soft Tissue Neoplasm
• Soft Tissue Cancer
• Soft Tissue Lesion

Interventions

Type	Name	Description
OTHER	Medical Record Review	Data will be collected from the participants medical records.

Timeline

• Start date: 2026-01-29
• Primary completion: 2030-08-08
• Completion: 2031-08-08
• First posted: 2026-03-13
• Last updated: 2026-03-17

Locations

1 site across 1 country: United States