Ultrasound to Facilitate Stone Passage

Urinary Calculi Clinical Trial

Official title:

Ultrasound Technology to Fragment and Reposition Urinary Stones

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04796792
• Other study ID #: STUDY00011687
• Secondary ID: 5P01DK043881-26
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: October 31, 2028

Study information

• Verified date: March 2023
• Source: University of Washington
• Contact: Michael Bailey, PhD
• Phone: 206-619-2035
• Email: mbailey[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: October 31, 2028
• Est. primary completion date: May 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Individuals presenting with at least one kidney stone

• Stone with maximum dimension > 2 mm and = 7 mm as determined by clinical imaging

• Individuals with SCI - (Phase 2b only)

Exclusion Criteria:

• Individuals under 18 years of age

• Individuals who are pregnant or who are trying to get pregnant

• Prisoners

• with cognitive impairment that would limit their ability to comprehend their role in consent or participation.

• Individuals who are unable to read or understand English

• Individuals who are unable or unwilling to participate in follow up activities

• Individuals who cannot be positioned for ultrasound imaging

• Individuals with uncorrected bleeding disorders or coagulopathies

• Individuals receiving anticoagulants and who are unable or not willing to temporarily cease the medication for the investigational procedure

• Individuals with a calcified abdominal aortic aneurysm or calcified renal artery aneurysm ipsilateral to the renal stone targeted by the investigational procedure

• Individuals with a solitary kidney

• Individuals with an uncorrected urinary tract obstruction

• Individuals with an untreated infection

• Individuals with a comorbidity risk which, at the discretion of the physician, would make the patient a poor candidate for the investigational procedure

• Individuals who have received two previous investigational procedures for the same stone target

• Individuals who have undergone the investigational procedure within the last 21 days or still have unresolved AEs from a previous investigational procedure.

Related Conditions & MeSH terms

• Calculi
• Urinary Calculi
• Urinary Stone
• Urolithiasis

Intervention

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.

Locations

Country	Name	City	State
United States	Indiana University Health - North Hospital	Carmel	Indiana
United States	University of Washington	Seattle	Washington
United States	VA Puget Sound Health Care System	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
University of Washington	Indiana University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), VA Puget Sound Health Care System

Country where clinical trial is conducted

United States, 

References & Publications (7)

Dai JC, Sorensen MD, Chang HC, Samson PC, Dunmire B, Cunitz BW, Thiel J, Liu Z, Bailey MR, Harper JD. Quantitative Assessment of Effectiveness of Ultrasonic Propulsion of Kidney Stones. J Endourol. 2019 Oct;33(10):850-857. doi: 10.1089/end.2019.0340. Epub — View Citation

Harper JD, Cunitz BW, Dunmire B, Lee FC, Sorensen MD, Hsi RS, Thiel J, Wessells H, Lingeman JE, Bailey MR. First in Human Clinical Trial of Ultrasonic Propulsion of Kidney Stones. J Urol. 2016 Apr;195(4 Pt 1):956-64. doi: 10.1016/j.juro.2015.10.131. Epub — View Citation

Harper JD, Metzler I, Hall MK, Chen TT, Maxwell AD, Cunitz BW, Dunmire B, Thiel J, Williams JC, Bailey MR, Sorensen MD. First In-Human Burst Wave Lithotripsy for Kidney Stone Comminution: Initial Two Case Studies. J Endourol. 2021 Apr;35(4):506-511. doi: — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - incidence of return healthcare visits.	Incidence of return health care visits associated with the device or procedure.	Day of procedure to 14 months post-procedure
Primary	Effectiveness - stone comminution into fragments 2 mm or less.	Number of cases where the largest dimension of any residual stone in the study kidney is less than or equal to 2 mm.	Day of procedure to 4 months posts procedure
Secondary	Safety - incidence of adverse events (AEs)	The incidence of all adverse events (AEs) associated with the device or procedure	Day of procedure to 4 months posts procedure
Secondary	Effectiveness - % residual stone volume	Residual stone volume relative to the initial stone volume	Day of procedure to 4 months posts procedure
Secondary	Effectiveness - need for further stone management	Incidence of new healthcare visits for further stone management	Day of procedure to 4 months posts procedure
Secondary	Effectiveness - Outcome from Wisconsin Stone Quality of Life questionnaire	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/.	Day of procedure to 14 months posts procedure

External Links

•   Sponsor website