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| Name | Class |
|---|---|
| VA Puget Sound Health Care System | FED |
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This study tests moving kidney stones using focused ultrasound (referred to as ultrasonic propulsion). The study includes multiple population groups to investigate the ability of our technology to: a) move stone fragments to a location within the kidney to improve their chances of passage, and thus reduce the occurrence of additional symptomatic events and retreatment or b) move a symptomatic stone to relieve symptoms and pain.
This is an investigator initiated, NIH-funded study conducted by the University of Washington (UW). Our research group has developed a new, non-invasive technology using low intensity focused ultrasound to reposition kidney stones by imparting sufficient acoustic energy to physically move a stone. The focused ultrasound pulses are similar to pulses that may be used in elastography or acoustic radiation force imaging. Like conventional ultrasound, the probe is placed in contact with the patient's skin to image the stone following standard ultrasound imaging procedure. The same probe is then used to focus the ultrasound and apply a burst (a sequence of pulses) of acoustic force to push the stone. Brightness mode (B-mode) imaging is interleaved with the "pushing" pulses (Push-mode) to monitor stone movement. The user controls the burst amplitude. To limit heating at the probe surface, there is a slight delay before the operator can execute the next push.
In addition to undergoing the investigational procedure, the research activities include the following:
Subjects that qualify for the trial are recruited into different study arms (referred to as Population groups) based on their type of stone condition (de novo stone versus post-lithotripsy fragment), size of stone (≤ 5 mm or > 5 mm), and management plan (clinical observation or surgical intervention). The objectives vary based upon the Population group. Subjects may qualify for more than one population group and may undergo the investigational procedure up to 4 times total (inclusive of both the left and right-side urinary tracts). Subjects can only be enrolled in one population group at a time, there is a separate consent for each study population, and each study population is considered independent of the other groups. Recruitment into all population groups has been completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First in Human (FIH) | Experimental | Initial phase of the trial. Includes a broad spectrum of population groups (e.g. de novo, concurrent with URS, residual fragments) to demonstrate feasibility. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter. Procedure conducted with the Propulse 1 device and C5-2 transducer. Subjects (n = 15) receive up to 40 push bursts. |
|
| De Novo Small Stone | Experimental | Segment of the trial focused specifically on subjects with small (≤ 5 mm) stones under observation management. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter with the goal to facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 2) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity. |
|
| Concurrent with URS | Experimental | Segment of the trial focused specifically on subjects undergoing ultrasonic propulsion concurrently with their ureteroscopy guided laser lithotripsy procedure. Study provides visual observation of stone motion and any potential tissue injury. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 18) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propulse 1 with C5-2 probe | Device | Move kidney stones with Propulse 1 device. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Stone Motion Caused by Ultrasound | Percentage of study participants for which stone motion was observed on the real-time ultrasound images. | At the time of the procedure. To be evaluated with each therapy pulse over an approximately 1-hour study. Confirmed with post-procedure review of the study video. |
| Measurement of Stone Passage | The percentage of participants reporting visual observation of stone passage or confirmed with follow-up imaging. For the residual fragment RCT population specifically, the percentage of participants reporting visual observation of stone passage during the 3-week follow-up period after the procedure or randomization (Control group). | Measurement occurs over 3 weeks (weekly phone call or email encounter with the subject) plus review of the subject's medical chart up to the point the subject is exited from the study. |
| Measurement of Relapse | The percentage of participants experiencing stone relapse defined as: an unscheduled, symptomatic visit for stones on the study side, surgery for stones on the study side, or stone growth of a residual fragment measured by clinical imaging exams. This measurement is specific to the residual fragment population and associated randomized control trial. Only a single relapse event is counted per participant, though a participant could experience more than one event. | Measurement up to 5 years post-procedure. This includes a phone call or email exchange semi-annually for up to 3-years and a medical record review (including imaging) semi-annually for up to 5-years. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Discomfort Related to the Device or Procedure | Pre-Procedure: The participant will be asked directly what discomfort, on a scale of 0 (no pain) to 10 (worst pain possible), they are experiencing and to point to where the discomfort/pain is located. This is the participant's recorded baseline measure. During Procedure: The participant will be asked directly if they are experiencing any new or different discomfort, on a scale of 0 (no pain) to 10 (worst pain possible), and to point to where the discomfort/pain is located. Any new or different discomfort above baseline will be assumed related to the device or procedure; there is no minimum threshold for reporting. Post Procedure: The participant will be asked directly what discomfort, on a scale of 0 (no pain) to 10 (worst pain possible), they are experiencing and to point to where the discomfort/pain is located. Any new or different discomfort above baseline will be assumed related to the device or procedure; there is no minimum threshold for reporting. |
Inclusion Criteria:
Individuals suspected of having at least one kidney stone. This includes:
Or
Individuals suspected of having an obstructed stone. This includes:
Primary Exclusion Criteria for all groups:
Additional Exclusion Criteria for Obstructing Stone population
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Harper, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Puget Sound Health Care System | Seattle | Washington | 98108 | United States | ||
| University of Washington Department of Urology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36205340 | Result | Hall MK, Thiel J, Dunmire B, Samson PC, Kessler R, Sunaryo P, Sweet RM, Metzler IS, Chang HC, Gunn M, Dighe M, Anderson L, Popchoi C, Managuli R, Cunitz BW, Burke BH, Ding L, Gutierrez B, Liu Z, Sorensen MD, Wessells H, Bailey MR, Harper JD. First Series Using Ultrasonic Propulsion and Burst Wave Lithotripsy to Treat Ureteral Stones. J Urol. 2022 Nov;208(5):1075-1082. doi: 10.1097/JU.0000000000002864. Epub 2022 Nov 1. | |
| 31333058 |
| Label | URL |
|---|---|
| Link to a page at the University of Washingon Applied Physics Laboratory website that provides additional information on ultrasonic propulsion. | View source |
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172 subjects are considered enrolled in this study for one of the groups defined below.
249 subjects were consented for the study. 77 subjects screen failed after consent but before undergoing any ultrasonic propulsion procedure. Since these subjects did not qualify for the study and were not assigned to an arm/group, they are not considered enrolled or included in the data provided below. The start of the study is defined as receiving at least one ultrasonic propulsion therapy pulse.
Participants were recruited based on physician referral and identification of potential qualifying individuals through review of the clinic patient list. Participants were recruited between December of 2013 and July of 2024. The first participant was enrolled on December 17, 2013 and the last participant was enrolled on July 23, 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | First in Human (FIH) | Initial phase of the trial. Includes a broad spectrum of population groups (e.g. de novo, concurrent with URS, residual fragments) to demonstrate feasibility. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter. Procedure conducted with the Propulse 1 device and C5-2 transducer. Subjects (n = 15) receive up to 40 push bursts. Propulse 1: Move kidney stones with Propulse 1 device. |
| FG001 | De Novo Small Stone | Segment of the trial focused specifically on subjects with small (< 5 mm) stones under observation management. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter with the goal to facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 2) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity. Propulse 1: Move kidney stones with Propulse 1 device. |
| FG002 | Concurrent With URS | Segment of the trial focused specifically on subjects undergoing ultrasonic propulsion concurrently with their URS laser lithotripsy procedure. Study provides visual observation of stone motion and any potential tissue injury. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 18) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity. Propulse 1: Move kidney stones with Propulse 1 device. |
| FG003 | Obstructing Stone - Pushing Only | Segment of the trial focused specifically on subjects reporting to clinic or the emergency deparment with an obstructing stone. Intervention consists of the non-invasive application of ultrasound to relieve pain and facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 16) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity. Propulse 1: Move kidney stones with Propulse 1 device. |
| FG004 | Obstructing Stone - Dislodging + Pushing | Segment of the trial focused specifically on subjects reporting to clinic or the emergency department with an obstructing stone. Participants were separate from the Obstructing Stone - Pushing only group based on the selection of participants with stone skin-to-stone distance < 8 mm. Intervention consists of the non-invasive application of ultrasound to relieve pain and facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 13) receive both Dislodging and Push bursts up to a maximum cumulative dose exposure of 5 minutes. This is the only population to receive the Dislodging bursts, which consist of higher amplitude (up to 7 MPa) and shorter duration pulses compared to pushing. The Push burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity. |
| FG005 | Residual Fragment (Treatment Group) | Segment of the trial focused specifically on subjects with small (< 5 mm) residual fragments following lithotripsy. This is the Treatment arm of a randomized control trial. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter with the goal to facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 54) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity. Propulse 1: Move kidney stones with Propulse 1 device. |
| FG006 | Residual Fragment (Control Group) | Segment of the trial focused specifically on subjects with small (< 5 mm) residual fragments following lithotripsy. This is the Control arm of a randomized control trial. Subjects (n = 54) follow same protocol as Residual Fragment (Treatment group) but do not receive the ultrasonic propulsion intervention. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | First in Human (FIH) | Initial phase of the trial. Includes a broad spectrum of population groups (e.g. de novo, concurrent with URS, residual fragments) to demonstrate feasibility. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter. Procedure conducted with the Propulse 1 device and C5-2 transducer. Subjects (n = 15) receive up to 40 push bursts . Propulse 1: Move kidney stones with Propulse 1 device. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Measurement of Stone Motion Caused by Ultrasound | Percentage of study participants for which stone motion was observed on the real-time ultrasound images. | All subjects who were exposed to at least one ultrasonic propulsion burst. | Posted | Count of Participants | Participants | At the time of the procedure. To be evaluated with each therapy pulse over an approximately 1-hour study. Confirmed with post-procedure review of the study video. |
|
AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | First in Human (FIH) | Initial phase of the trial. Includes a broad spectrum of population groups (e.g. de novo, concurrent with URS, residual fragments) to demonstrate feasibility. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter. Procedure conducted with the Propulse 1 device and C5-2 transducer. Subjects (n = 15) receive up to 40 push bursts. Propulse 1: Move kidney stones with Propulse 1 device. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment | Event was adjudicated as not related to the investigational procedure, but a response to the anesthesia required for the URS procedure (URS case) and participant's choice of stopping meds (Obstructing Stone case). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Effects | Skin and subcutaneous tissue disorders | Systematic Assessment | Includes mild cases of skin redness, irritation, or bruising. No skin blistering or breakage was observed. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Bailey | University of Washington | 206 - 685 - 8618 | mbailey@uw.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 30, 2022 | Mar 24, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D053040 | Nephrolithiasis |
| D052878 | Urolithiasis |
| D002137 | Calculi |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Population groups 1-4 are single groups. Subjects are assigned based upon their underlying stone condition and the stage of the trial. Subjects enrolled into the residual fragment population (group 5) are randomized between a treatment group and concurrent control group.
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Outcome Assessors evaluating: a) imaging for stone growth, b) relatedness of safety events to the device/procedure or underlying stone condition, and c) relapse events, for the residual fragment (RCT) population are blind to the exposure condition.
| Obstructing Stone - Pushing only |
| Experimental |
Segment of the trial focused specifically on subjects reporting to clinic or the emergency department with an obstructing stone. Intervention consists of the non-invasive application of ultrasound to relieve pain and facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 16) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity. |
|
| Residual Fragment (Treatment group) | Experimental | Segment of the trial focused specifically on subjects with small (≤ 5 mm) residual fragments following lithotripsy. This is the Treatment arm of a randomized control trial. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter with the goal to facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 54) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity. |
|
| Residual Fragment (Control group) | No Intervention | Segment of the trial focused specifically on subjects with small (≤ 5 mm) residual fragments following lithotripsy. This is the Control arm of a randomized control trial. Subjects (n = 54) follow same protocol as Residual Fragment (Treatment group) but do not receive the ultrasonic propulsion intervention. |
| Obstructing Stone - Pushing + Dislodging | Experimental | Segment of the trial focused specifically on subjects reporting to clinic or the emergency department with an obstructing stone. Participants were separate from the Obstructing Stone - Pushing only based on a stone skin-to-stone distance < 8 mm. Intervention consists of the non-invasive application of ultrasound to relieve pain and facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 13) receive both Dislodging and Push bursts up to a maximum cumulative dose exposure of 5 minutes. This is the only population to receive the Dislodging bursts, which consist of higher amplitude (up to 7 MPa) and shorter duration pulses compared to pushing. The Push burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity. |
|
| Propulse 1 with SC-X probe |
| Device |
Move kidney stones with Propulse 1 device. |
|
| At the time of the procedure. To be evaluated over an approximately 1 hour study. |
| Seattle |
| Washington |
| 98195 |
| United States |
| Result |
| 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. |
| 26521719 | Result | 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. |
| 39146526 | Result | Sorensen MD, Dunmire B, Thiel J, Cunitz BW, Burke BH, Levchak BJ, Popchoi C, Holmes AE, Kucewicz JC, Hall MK, Dighe M, Dai JC, Cormack FC, Liu Z, Bailey MR, Porter MP, Harper JD. Randomized Controlled Trial of Ultrasonic Propulsion-Facilitated Clearance of Residual Kidney Stone Fragments vs Observation. J Urol. 2024 Dec;212(6):811-820. doi: 10.1097/JU.0000000000004186. Epub 2024 Aug 15. |
| 40030414 | Result | Yang CC, Keating EE, Managuli R, Honssinger N, Holt SK, Desai AC. A Randomized Controlled Trial of Ultrasonic Propulsion-Facilitated Clearance of Residual Renal Stone Fragments vs Observation. J Urol. 2025 Jul;214(1):3-9. doi: 10.1097/JU.0000000000004501. Epub 2025 Mar 3. |
| 32940089 | Derived | 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. |
| Death |
|
| Protocol Violation |
|
| Underwent standard-of-care surgery |
|
| BG001 | De Novo Small Stone | Segment of the trial focused specifically on subjects with small (< 5 mm) stones under observation management. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter with the goal to facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 2) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity. Propulse 1: Move kidney stones with Propulse 1 device. |
| BG002 | Concurrent With URS | Segment of the trial focused specifically on subjects undergoing ultrasonic propulsion concurrently with their URS laser lithotripsy procedure. Study provides visual observation of stone motion and any potential tissue injury. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 18) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity. Propulse 1: Move kidney stones with Propulse 1 device. |
| BG003 | Obstructing Stone - Pushing Only | Segment of the trial focused specifically on subjects reporting to clinic or the emergency deparment with an obstructing stone. Intervention consists of the non-invasive application of ultrasound to relieve pain and facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 16) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity. A second obstructing stone population (n = 13) also receives higher amplitude (up to 7 MPa) shorter duration dislodging pulses. Propulse 1: Move kidney stones with Propulse 1 device. |
| BG004 | Obstructing Stone - Dislodging + Pushing | Segment of the trial focused specifically on subjects reporting to clinic or the emergency department with an obstructing stone. Participants were separate from the Obstructing Stone - Pushing only group based on the selection of participants with stone skin-to-stone distance < 8 mm. Intervention consists of the non-invasive application of ultrasound to relieve pain and facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 13) receive both Dislodging and Push bursts up to a maximum cumulative dose exposure of 5 minutes. This is the only population to receive the Dislodging bursts, which consist of higher amplitude (up to 7 MPa) and shorter duration pulses compared to pushing. The Push burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity. |
| BG005 | Residual Fragment (Treatment Group) | Segment of the trial focused specifically on subjects with small (< 5 mm) residual fragments following lithotripsy. This is the Treatment arm of a randomized control trial. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter with the goal to facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 54) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity. Propulse 1: Move kidney stones with Propulse 1 device. |
| BG006 | Residual Fragment (Control Group) | Segment of the trial focused specifically on subjects with small (< 5 mm) residual fragments following lithotripsy. This is the Control arm of a randomized control trial. Subjects (n = 54) follow same protocol as Residual Fragment (Treatment group) but do not receive the ultrasonic propulsion intervention. |
| BG007 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body-Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Renal Side | Side target stone(s) is on. Measured as Left - L or Right - R | Analysis Population includes both kidneys if more than one side is targeted in a single session. This applies specifically to the FIH population and the URS population, where both kidneys were targeted in a single subject (which counts as two kidney units). | Number | Participants |
|
| Target (Stone) Location | Participants could have multiple targets and targets in multiple locations. | Number | Number of Targets (Stone) |
|
| OG001 | De Novo Small Stone | Segment of the trial focused specifically on subjects with small (< 5 mm) stones under observation management. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter with the goal to facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 2) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity. Propulse 1: Move kidney stones with Propulse 1 device. |
| OG002 | Concurrent With URS | Segment of the trial focused specifically on subjects undergoing ultrasonic propulsion concurrently with their URS laser lithotripsy procedure. Study provides visual observation of stone motion and any potential tissue injury. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 18) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity. Propulse 1: Move kidney stones with Propulse 1 device. |
| OG003 | Obstructing Stone - Pushing Only | Segment of the trial focused specifically on subjects reporting to clinic or the emergency deparment with an obstructing stone. Intervention consists of the non-invasive application of ultrasound to relieve pain and facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 16) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity. A second obstructing stone population (n = 13) also receives higher amplitude (up to 7 MPa) shorter duration dislodging pulses. Propulse 1: Move kidney stones with Propulse 1 device. |
| OG004 | Obstructing Stone - Dislodging + Pushing | Segment of the trial focused specifically on subjects reporting to clinic or the emergency department with an obstructing stone. Participants were separate from the Obstructing Stone - Pushing only group based on the selection of participants with stone skin-to-stone distance < 8 mm. Intervention consists of the non-invasive application of ultrasound to relieve pain and facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 13) receive both Dislodging and Push bursts up to a maximum cumulative dose exposure of 5 minutes. This is the only population to receive the Dislodging bursts, which consist of higher amplitude (up to 7 MPa) and shorter duration pulses compared to pushing. The Push burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity. |
| OG005 | Residual Fragment (Treatment Group) | Segment of the trial focused specifically on subjects with small (< 5 mm) residual fragments following lithotripsy. This is the Treatment arm of a randomized control trial. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter with the goal to facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 54) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity. Propulse 1: Move kidney stones with Propulse 1 device. |
| OG006 | Residual Fragment (Control Group) | Segment of the trial focused specifically on subjects with small (< 5 mm) residual fragments following lithotripsy. This is the Control arm of a randomized control trial. Subjects (n = 54) follow same protocol as Residual Fragment (Treatment group) but do not receive the ultrasonic propulsion intervention. |
|
|
| Primary | Measurement of Stone Passage | The percentage of participants reporting visual observation of stone passage or confirmed with follow-up imaging. For the residual fragment RCT population specifically, the percentage of participants reporting visual observation of stone passage during the 3-week follow-up period after the procedure or randomization (Control group). | Outcome is appropriate for participants with a de novo small stone, obstructing stone, or residual fragment population. Outcome is not appropriate for participants undergoing the procedure concurrently with URS. There is no means to differentiate fragments passed as a result of their standard-of-care lithotripsy procedure versus fragments that passed as a result of the ultrasonic propulsion - since both are done concurrently. | Posted | Count of Participants | Participants | Measurement occurs over 3 weeks (weekly phone call or email encounter with the subject) plus review of the subject's medical chart up to the point the subject is exited from the study. |
|
|
|
| Primary | Measurement of Relapse | The percentage of participants experiencing stone relapse defined as: an unscheduled, symptomatic visit for stones on the study side, surgery for stones on the study side, or stone growth of a residual fragment measured by clinical imaging exams. This measurement is specific to the residual fragment population and associated randomized control trial. Only a single relapse event is counted per participant, though a participant could experience more than one event. | Outcome was only pre-specified for the Residual Fragment population, which was a randomized trial that included a Treatment group (who underwent the ultrasonic propulsion procedure) and a concurrent Control group (that did not receive the ultrasonic propulsion procedure). Study follow up was limited to 90 days for all other populations. | Posted | Count of Participants | Participants | Measurement up to 5 years post-procedure. This includes a phone call or email exchange semi-annually for up to 3-years and a medical record review (including imaging) semi-annually for up to 5-years. |
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| Other Pre-specified | Number of Participants With Discomfort Related to the Device or Procedure | Pre-Procedure: The participant will be asked directly what discomfort, on a scale of 0 (no pain) to 10 (worst pain possible), they are experiencing and to point to where the discomfort/pain is located. This is the participant's recorded baseline measure. During Procedure: The participant will be asked directly if they are experiencing any new or different discomfort, on a scale of 0 (no pain) to 10 (worst pain possible), and to point to where the discomfort/pain is located. Any new or different discomfort above baseline will be assumed related to the device or procedure; there is no minimum threshold for reporting. Post Procedure: The participant will be asked directly what discomfort, on a scale of 0 (no pain) to 10 (worst pain possible), they are experiencing and to point to where the discomfort/pain is located. Any new or different discomfort above baseline will be assumed related to the device or procedure; there is no minimum threshold for reporting. | All subjects who were exposed to at least one ultrasonic propulsion burst. Analysis population does not include the "Concurrent with URS" group as the participants are not awake for the procedure. | Posted | Count of Participants | Participants | At the time of the procedure. To be evaluated over an approximately 1 hour study. |
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| 0 |
| 15 |
| 0 |
| 15 |
| 3 |
| 15 |
| EG001 | De Novo Small Stone | Segment of the trial focused specifically on subjects with small (< 5 mm) stones under observation management. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter with the goal to facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 2) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity. Propulse 1: Move kidney stones with Propulse 1 device. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG002 | Concurrent With URS | Segment of the trial focused specifically on subjects undergoing ultrasonic propulsion concurrently with their URS laser lithotripsy procedure. Study provides visual observation of stone motion and any potential tissue injury. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 18) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity. Propulse 1: Move kidney stones with Propulse 1 device. | 0 | 18 | 1 | 18 | 2 | 18 |
| EG003 | Obstructing Stone - Pushing Only | Segment of the trial focused specifically on subjects reporting to clinic or the emergency deparment with an obstructing stone. Intervention consists of the non-invasive application of ultrasound to relieve pain and facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 16) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity. A second obstructing stone population (n = 13) also receives higher amplitude (up to 7 MPa) shorter duration dislodging pulses. Propulse 1: Move kidney stones with Propulse 1 device. | 0 | 16 | 1 | 16 | 1 | 16 |
| EG004 | Obstructing Stone - Dislodging + Pushing | Segment of the trial focused specifically on subjects reporting to clinic or the emergency department with an obstructing stone. Participants were separate from the Obstructing Stone - Pushing only group based on the selection of participants with stone skin-to-stone distance < 8 mm. Intervention consists of the non-invasive application of ultrasound to relieve pain and facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 13) receive both Dislodging and Push bursts up to a maximum cumulative dose exposure of 5 minutes. This is the only population to receive the Dislodging bursts, which consist of higher amplitude (up to 7 MPa) and shorter duration pulses compared to pushing. The Push burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity. | 0 | 13 | 0 | 13 | 6 | 13 |
| EG005 | Residual Fragment (Treatment Group) | Segment of the trial focused specifically on subjects with small (< 5 mm) residual fragments following lithotripsy. This is the Treatment arm of a randomized control trial. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter with the goal to facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 54) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity. Propulse 1: Move kidney stones with Propulse 1 device. | 1 | 54 | 0 | 54 | 31 | 54 |
| EG006 | Residual Fragment (Control Group) | Segment of the trial focused specifically on subjects with small (< 5 mm) residual fragments following lithotripsy. This is the Control arm of a randomized control trial. Subjects (n = 54) follow same protocol as Residual Fragment (Treatment group) but do not receive the ultrasonic propulsion intervention. | 3 | 54 | 0 | 54 | 20 | 54 |
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| Pain | Nervous system disorders | Systematic Assessment | Report of any discomfort experienced by the participant post-procedure. |
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| Hematuria | Renal and urinary disorders | Systematic Assessment |
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| Change in Urinary Frequency | Renal and urinary disorders | Systematic Assessment |
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| Change in Urinary Urgency | Renal and urinary disorders | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Emesis | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Change in other Voiding Habits (i.e. slow flow) | Renal and urinary disorders | Systematic Assessment |
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Not provided
Not provided
Not provided
| D000091642 | Urogenital Diseases |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |