# In-Office, Ultrasound-Based Breakage and Removal of Urinary stones

> **NIH NIH P01** · UNIVERSITY OF WASHINGTON · 2020 · $1,567,293

## Abstract

OVERALL SUMMARY
 The main focus of this Program Project Grant is to discover the foundational and translational
knowledge needed to create an office-based handheld ultrasound device to target, detach, break, and
expel stones and stone fragments from the urinary space to facilitate natural clearance. This system will
obviate costly and inefficient emergency department visits that typically include repetitive exposure to
ionizing radiation from diagnostic imaging, and will significantly reduce the often lengthy (days to weeks)
wait time patients must endure before procedures for stone removal can be scheduled and performed.
As the proposed therapy system is entirely noninvasive, patients will be treated on an outpatient basis.
Further, as the system is designed to efficiently and painlessly break stones of any size and expel the
fragments from the kidney, the treatment of both symptomatic and asymptomatic stones using this
technology will reduce the high retreatment and stone event recurrence rates associated with current
surgical interventions for stone removal.
 In this effort, we will combine stone breakage by burst wave lithotripsy (BWL), clearance of fragments
by ultrasonic propulsion (UP), and stone-specific ultrasound imaging (S-mode) into an integrated system
in which exposure strategies are adapted during treatment in response to real-time acoustic feedback to
enhance comminution efficiency and patient safety. We will tailor treatment by investigating numerically
and in lab tests the primary mechanisms - cavitation and elastic waves - involved in the comminution
process over a broad parameter space. We will develop acoustics-based feedback including model-
based, machine learning and passive acoustic mapping (PAM) of the bubble field to signal the need to
adjust the energy output. We will investigate the morphological and functional response of the kidney in
living animals and in ex vivo perfused porcine kidneys, and pursue tissue protective treatment strategies
such as power ramping.
 These studies will include the first in-human test of BWL in which we will compare the comminution
effectiveness and safety of treatment with and without adaptive output control in response to acoustic
feedback. In addition, we will conduct a randomized controlled trial of the benefits and risks of fragmenting
and expelling symptomatic and asymptomatic stones in the clinic. Toward application of the system for
use in humans, we will refine and validate the use of UP and S-mode together to improve stone and
fragment detection. With our eye on the future of stone management, we will develop and validate in vivo
an extracorporeal acoustic tractor beam to grasp and carry fragments through the complex three-
dimensional path of the urinary space and out of the kidney.

## Key facts

- **NIH application ID:** 10005352
- **Project number:** 5P01DK043881-26
- **Recipient organization:** UNIVERSITY OF WASHINGTON
- **Principal Investigator:** MICHAEL R BAILEY
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,567,293
- **Award type:** 5
- **Project period:** 1997-03-01 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10005352

## Citation

> US National Institutes of Health, RePORTER application 10005352, In-Office, Ultrasound-Based Breakage and Removal of Urinary stones (5P01DK043881-26). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10005352. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*