Ultrasound to Facilitate Stone Passage
Study Details
Study Description
Brief Summary
This is a prospective, open-label, multi-center study to test the clinical feasibility of facilitating stone passage by the combination of breaking and repositioning stones with ultrasound, without the need for anesthesia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
This is a prospective, open-label, multi-center study to test the clinical feasibility of facilitating stone passage by the combination of breaking and repositioning stones with ultrasound, without the need for anesthesia.
Subjects will be included across three phases:
Phase 1: 20 subjects to demonstrate initial feasibility Phase 2a: 100 subjects for a two-arm (50:50) randomized control trial (RCT) Phase 2b: 20 subjects to demonstrate feasibility in individuals with spinal cord injury (SCI)
This study is currently in Phase 1. Phase 2a and 2b are intended to be conducted in parallel and will not be initiated until after review of the Phase 1 results and approval to proceed to Phase 2 by the FDA.
Up to 3 distinct targets may be treated per subject. The maximum total dose exposure is 30 minutes for one session. Subjects may return after at least 21 days and after all AEs have resolved for an additional session on the same side. Subjects may return after imaging follow-up for inclusion of their contralateral side.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment group This study is currently in Phase 1 where all subjects undergo the investigational study. |
Device: Break Wave Lithotripsy and Ultrasonic Propulsion
Novel ultrasound technologies to facilitate passage of stones.This includes Burst Wave Lithotripsy (BWL), a technology to noninvasively fragment urinary calculi within the kidney and ureter, and ultrasonic propulsion, a technology to non-invasively reposition stones within the kidney and ureter. BWL uses short multi-cycle bursts of low amplitude ultrasound to induce stone fracture. This is in contrast to traditional extracorporeal shock wave lithotripsy (SWL), which employs a brief single compression/tensile cycle of high amplitude (shock) waves to achieve stone fracture. Ultrasonic propulsion uses long multi-cycle bursts of low amplitude ultrasound to move stones within the collecting system.
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Outcome Measures
Primary Outcome Measures
- Safety - incidence of return healthcare visits. [Day of procedure to 14 months post-procedure]
Incidence of return health care visits associated with the device or procedure.
- Effectiveness - stone comminution into fragments 2 mm or less. [Day of procedure to 4 months posts procedure]
Number of cases where the largest dimension of any residual stone in the study kidney is less than or equal to 2 mm.
Secondary Outcome Measures
- Safety - incidence of adverse events (AEs) [Day of procedure to 4 months posts procedure]
The incidence of all adverse events (AEs) associated with the device or procedure
- Effectiveness - % residual stone volume [Day of procedure to 4 months posts procedure]
Residual stone volume relative to the initial stone volume
- Effectiveness - need for further stone management [Day of procedure to 4 months posts procedure]
Incidence of new healthcare visits for further stone management
- Effectiveness - Outcome from Wisconsin Stone Quality of Life questionnaire [Day of procedure to 14 months posts procedure]
Quality of life, evaluated by the comparison of Wisconsin Stone Quality of Life (WISQOL) questionnaire scores before and after the investigational procedure. The questionnaire consists of a series of questions to evaluate the symptomatic and functional impact of the stones on a scale of 1 to 5, where a lower score indicates a greater impact. https://urology.wisc.edu/research/wisqol/.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Individuals presenting with at least one kidney stone
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Stone with maximum dimension > 2 mm and ≤ 7 mm as determined by clinical imaging
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Individuals with SCI - (Phase 2b only)
Exclusion Criteria:
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Individuals under 18 years of age
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Individuals who are pregnant or who are trying to get pregnant
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Prisoners
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with cognitive impairment that would limit their ability to comprehend their role in consent or participation.
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Individuals who are unable to read or understand English
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Individuals who are unable or unwilling to participate in follow up activities
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Individuals who cannot be positioned for ultrasound imaging
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Individuals with uncorrected bleeding disorders or coagulopathies
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Individuals receiving anticoagulants and who are unable or not willing to temporarily cease the medication for the investigational procedure
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Individuals with a calcified abdominal aortic aneurysm or calcified renal artery aneurysm ipsilateral to the renal stone targeted by the investigational procedure
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Individuals with a solitary kidney
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Individuals with an uncorrected urinary tract obstruction
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Individuals with an untreated infection
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Individuals with a comorbidity risk which, at the discretion of the physician, would make the patient a poor candidate for the investigational procedure
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Individuals who have received two previous investigational procedures for the same stone target
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Individuals who have undergone the investigational procedure within the last 21 days or still have unresolved AEs from a previous investigational procedure.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Indiana University Health - North Hospital | Carmel | Indiana | United States | 46032 |
| 2 | VA Puget Sound Health Care System | Seattle | Washington | United States | 98108 |
| 3 | University of Washington | Seattle | Washington | United States | 98195 |
Sponsors and Collaborators
- University of Washington
- Indiana University
- VA Puget Sound Health Care System
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
- Principal Investigator: Jonathan Harper, MD, University of Washington
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Maxwell AD, Cunitz BW, Kreider W, Sapozhnikov OA, Hsi RS, Harper JD, Bailey MR, Sorensen MD. Fragmentation of urinary calculi in vitro by burst wave lithotripsy. J Urol. 2015 Jan;193(1):338-44. doi: 10.1016/j.juro.2014.08.009. Epub 2014 Aug 9.
- Maxwell AD, Wang YN, Kreider W, Cunitz BW, Starr F, Lee D, Nazari Y, Williams JC Jr, Bailey MR, Sorensen MD. Evaluation of Renal Stone Comminution and Injury by Burst Wave Lithotripsy in a Pig Model. J Endourol. 2019 Oct;33(10):787-792. doi: 10.1089/end.2018.0886. Epub 2019 May 27.
- May PC, Kreider W, Maxwell AD, Wang YN, Cunitz BW, Blomgren PM, Johnson CD, Park JSH, Bailey MR, Lee D, Harper JD, Sorensen MD. Detection and Evaluation of Renal Injury in Burst Wave Lithotripsy Using Ultrasound and Magnetic Resonance Imaging. J Endourol. 2017 Aug;31(8):786-792. doi: 10.1089/end.2017.0202. Epub 2017 Jun 16.
- Ramesh S, Chen TT, Maxwell AD, Cunitz BW, Dunmire B, Thiel J, Williams JC, Gardner A, Liu Z, Metzler I, Harper JD, Sorensen MD, Bailey MR. In Vitro Evaluation of Urinary Stone Comminution with a Clinical Burst Wave Lithotripsy System. J Endourol. 2020 Nov;34(11):1167-1173. doi: 10.1089/end.2019.0873. Epub 2020 Mar 20.
- STUDY00011687
- 5P01DK043881-26