The HistoSonics Investigational System for Treatment of Primary Solid Renal Tumors Using Histotripsy

Sponsor
HistoSonics, Inc.
Study ID
NCT05432232
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HistoSonics Investigational System — DEVICE
    The HistoSonics Investigational System is intended for the non-invasive destruction of kidney tissue using histotripsy, a non-thermal mechanical process of focused ultrasound.

Study Details

The purpose of this trial is to evaluate the technical success and safety profile of the HistoSonics Investigational System for the treatment of primary solid renal tumors.

Key Dates

Start date
Mar 23, 2023
Status verified
Oct 2025
Primary completion
Dec 28, 2024
Completion
Jun 6, 2025

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HistoSonics Investigational System

Primary Outcome Measure

Primary Effectiveness: Technical Success [ Time Frame: Up to 36 hours after the index procedure ]

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