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Ultrasound to Facilitate Stone Passage

Primary Purpose

Urinary Stone, Urinary Calculi

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Break Wave Lithotripsy and Ultrasonic Propulsion

About this trial

This is an interventional treatment trial for Urinary Stone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Indiana University Health - North Hospital
VA Puget Sound Health Care System
University of Washington

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

This study is currently in Phase 1 where all subjects undergo the investigational study.

Outcomes

Primary Outcome Measures

Safety - incidence of return healthcare visits.

Incidence of return health care visits associated with the device or procedure.

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.

Secondary Outcome Measures

Safety - incidence of adverse events (AEs)

The incidence of all adverse events (AEs) associated with the device or procedure

Effectiveness - % residual stone volume

Residual stone volume relative to the initial stone volume

Effectiveness - need for further stone management

Incidence of new healthcare visits for further stone management

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/.

Full Information

NCT ID

NCT04796792

First Posted

March 3, 2021

Last Updated

March 29, 2023

Sponsor

University of Washington

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04796792

Brief Title

Ultrasound to Facilitate Stone Passage

Official Title

Ultrasound Technology to Fragment and Reposition Urinary Stones

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

July 1, 2023 (Anticipated)

Primary Completion Date

May 31, 2028 (Anticipated)

Study Completion Date

October 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Washington

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Stone, Urinary Calculi

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment group

Arm Type

Experimental

Arm Description

This study is currently in Phase 1 where all subjects undergo the investigational study.

Intervention Type

Device

Intervention Name(s)

Break Wave Lithotripsy and Ultrasonic Propulsion

Intervention Description

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.

Primary Outcome Measure Information:

Title

Safety - incidence of return healthcare visits.

Description

Incidence of return health care visits associated with the device or procedure.

Time Frame

Day of procedure to 14 months post-procedure

Title

Effectiveness - stone comminution into fragments 2 mm or less.

Description

Number of cases where the largest dimension of any residual stone in the study kidney is less than or equal to 2 mm.

Time Frame

Day of procedure to 4 months posts procedure

Secondary Outcome Measure Information:

Title

Safety - incidence of adverse events (AEs)

Description

The incidence of all adverse events (AEs) associated with the device or procedure

Time Frame

Day of procedure to 4 months posts procedure

Title

Effectiveness - % residual stone volume

Description

Residual stone volume relative to the initial stone volume

Time Frame

Day of procedure to 4 months posts procedure

Title

Effectiveness - need for further stone management

Description

Incidence of new healthcare visits for further stone management

Time Frame

Day of procedure to 4 months posts procedure

Title

Effectiveness - Outcome from Wisconsin Stone Quality of Life questionnaire

Description

Time Frame

Day of procedure to 14 months posts procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michael Bailey, PhD

Phone

206-619-2035

mbailey@uw.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Barbrina Dunmire, MS

mrbean@uw.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jonathan Harper, MD

Organizational Affiliation

University of Washington

Official's Role

Principal Investigator

Facility Information:

Facility Name

Indiana University Health - North Hospital

City

Carmel

State/Province

Indiana

ZIP/Postal Code

46032

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kimberly Smoot

ksmoot@iuhealth.org

First Name & Middle Initial & Last Name & Degree

James Lingeman, MD

Facility Name

VA Puget Sound Health Care System

City

Seattle

State/Province

Washington

ZIP/Postal Code

98108

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Branda Levchak

branda.levchak@va.gov

First Name & Middle Initial & Last Name & Degree

Claire Yang, MD

Facility Name

University of Washington

City

Seattle

State/Province

Washington

ZIP/Postal Code

98195

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael Bailey, PhD

Phone

206-619-2035

mbailey@uw.edu

First Name & Middle Initial & Last Name & Degree

Barbara Burke

burkeb3@uw.edu

First Name & Middle Initial & Last Name & Degree

Jonathan Harper, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28521550

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.

Results Reference

background

PubMed Identifier

25111910

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.

Results Reference

background

PubMed Identifier

32103689

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.

Results Reference

background

PubMed Identifier

31016998

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.

Results Reference

background

PubMed Identifier

32940089

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.

Results Reference

result

PubMed Identifier

31333058

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.

Results Reference

result

PubMed Identifier

26521719

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.

Results Reference

result

Links:

URL

http://www.apl.washington.edu/project/project.php?id=bwl

Description

Sponsor website

Learn more about this trial

Ultrasound to Facilitate Stone Passage

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