Key Points
- HistoSonics has announced the start of enrollment for their #HOPE4KIDNEY pivotal trial assessing the use of histotripsy to treat kidney tumors.
- The first treatment took place in Florida, and the multi-center trial will enroll up to 68 participants.
HistoSonics recently announced that the first participant has been treated in their #HOPE4KIDNEY pivotal clinical trial assessing the use of histotripsy to treat kidney tumors. The trial uses the company’s Edison platform, an image-guided sonic beam therapy system that employs histotripsy to noninvasively and mechanically destroy tissue.
The first participant was treated by urologist Michael McDonald MD, at AdventHealth in Celebration, Florida. In all, the multi-center, single-arm trial will enroll up to 68 participants.
“Our goal is to enable physicians to precisely target and destroy kidney tumors with our novel, noninvasive solution, avoiding the morbidity and complications seen with current invasive surgery or ablative techniques,” said HistoSonics President and CEO, Mike Blue.
The clinical trial builds upon data from the CAIN trial, a Phase I study assessing the safety and feasibility of using histotripsy to target primary solid renal tumors in 20 participants in the UK. It was named after the late Charles Cain, PhD, former Chair of Biomedical Engineering at the University of Michigan, co-inventor of histotripsy, and co-founder of HistoSonics, who passed away in March 2020.
The Edison system was granted US Food and Drug Administration clearance in October 2023 to treat liver tumors.
Read HistoSonics’ Press Release
For Patients
If you are interested in learning more about the #HOPE4KIDNEY trial, visit the clinicaltrials.gov page or contact a site nearest you.
AdventHealth Celebration
Celebration, Florida, USA
Contact: Tracy Rivera, RN at tracy.rivera@adventhealth.com
Northwell Health
Lake Success, New York, USA
Contact: Sharon Choi at schoi19@northwell.edu