신장 결석의 초음파 추진의 안전성과 유효성

실험적: 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.

장치: Propulse 1 with C5-2 probe

Move kidney stones with Propulse 1 device.

실험적: 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.

장치: Propulse 1 with SC-X probe

Move kidney stones with Propulse 1 device.

실험적: Concurrent with URS

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.

장치: Propulse 1 with SC-X probe

Move kidney stones with Propulse 1 device.

실험적: Obstructing Stone - Pushing only

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.

장치: Propulse 1 with SC-X probe

Move kidney stones with Propulse 1 device.

실험적: 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.

장치: Propulse 1 with SC-X probe

Move kidney stones with Propulse 1 device.

간섭 없음: 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.

실험적: Obstructing Stone - Pushing + Dislodging

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.

장치: Propulse 1 with SC-X probe

Move kidney stones with Propulse 1 device.

Measurement of Stone Motion Caused by Ultrasound

Percentage of study participants for which stone motion was observed on the real-time ultrasound images.

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 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.

시술과 관련된 모든 부작용 측정

이 연구는 맹검 검토자가 장치, 절차 또는 장치와 잠재적으로 관련이 있다고 판단한 3주간의 추적 조사를 통해 시술 후 발병한 이상사례(치료군) 또는 무작위 배정(대조군)의 피험자 수준 비율을 측정합니다. 대상의 기저 신장 질환. (두 SAP 모두에 대한 보조 끝점)

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.