Clinical trial NCT04796792: Ultrasound to Facilitate Stone Passage
Official title: Ultrasound Technology to Fragment and Reposition Urinary Stones
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Urinary Stone
Urinary Calculi
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Indiana University
name: VA Puget Sound Health Care System
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-03-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety - incidence of return healthcare visits.
timeFrame: Day of procedure to 14 months post-procedure
measure: Effectiveness - stone comminution into fragments 2 mm or less.
timeFrame: Day of procedure to 4 months posts procedure
Secondary outcomes:
measure: Safety - incidence of adverse events (AEs)
timeFrame: Day of procedure to 4 months posts procedure
measure: Effectiveness - % residual stone volume
timeFrame: Day of procedure to 4 months posts procedure
measure: Effectiveness - need for further stone management
timeFrame: Day of procedure to 4 months posts procedure
measure: Effectiveness - Outcome from Wisconsin Stone Quality of Life questionnaire
timeFrame: Day of procedure to 14 months posts procedure
Other outcomes:
Locations:
city: Carmel
country: United States
facility: Indiana University Health - North Hospital
state: Indiana
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Jonathan Harper, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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: 10.1089/end.2020.0725. Epub 2020 Nov 5.
citation: 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 2019 Sep 25.
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 2015 Oct 30.