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NCT03811171 · ClinicalTrials.gov registry record · NA
Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study
A NA study of Renal Calculi and Urinary Calculi, sponsored by SonoMotion.
- Recruiting
- Registry status
- NA
- Development phase
- 70
- Enrollment target
- 6
- Study locations
NCT03811171: Recruiting NA study of Renal Calculi and Urinary Calculi, sponsored by SonoMotion.
NCT03811171 is a NA study of Renal Calculi and Urinary Calculi that is actively recruiting participants, run by SonoMotion. The registered enrollment target is 70 participants, below the 249-participant average among 4 other Renal Calculi trials with a reported enrollment target (72% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03811171, a NA study of Renal Calculi and Urinary Calculi, is actively recruiting participants, sponsored by SonoMotion.
- RECRUITING
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
- 6
- Study locations
Study Summary
This is a prospective, open-label, multi-center, single-arm (non-randomized) study to assess the safety and effectiveness of breaking stones in the upper urinary tract using the SonoMotion Break Wave technology. Up to 30 subjects will be included. The procedure will be performed in a hospital surgical environment as an outpatient (without being admitted) or in a non-surgical environment such as a clinic or office procedure room. The procedure will be performed under varying levels of anesthesia ranging from no anesthesia to general anesthesia (fully asleep). Stones will be limited to ≤ 10 mm for lower pole stones and ≤ 20 mm everywhere else. Safety will be measured by the self-reported occurrences of adverse events, unplanned emergency department or clinic visits, and the need for further intervention. Fragmentation will be measured by self-reported stone passage and a comparison of computed tomography (CT) images before and after the procedure.
Primary Outcome
Stone fragmentation as determined by stone passage or imaging confirmation.
Conditions Studied
Interventions
- DEVICE Break Wave extracorporeal lithotripsy
Study Locations (6)
California
- University of California San Diego Health - San Diego
- University of California, San Francisco - San Francisco
Washington
- University of Washington Medical Center - Seattle
Alberta
- University of Alberta, Division of Urology - Edmonton
British Columbia
- Vancouver General Hospital Stone Centre - Vancouver
Ontario
- St. Michael's Unity Health Toronto - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2019-08-20 |
| Est. Completion | 2027-03-30 |
| Phase | NA |
What NCT03811171 shows while recruiting
NCT03811171 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 249-participant average among 4 other Renal Calculi trials with a reported enrollment target (72% lower).
The record links to 2 conditions, with Renal Calculi appearing as the primary indexed condition, and to 1 intervention - of which Break Wave extracorporeal lithotripsy is the first listed.
NCT03811171 lists 6 locations in 5 states (California, Washington, Alberta).
Frequently Asked Questions
What is clinical trial NCT03811171 about?
NCT03811171 is a clinical study titled "Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study". This is a prospective, open-label, multi-center, single-arm (non-randomized) study to assess the safety and effectiveness of breaking stones in the upper urinary tract using the SonoMotion Break Wave technology. Up to 30 subjects will be included. The procedure will be performed in a hospital surgic...
What is the current status of trial NCT03811171?
This trial is currently recruiting. It is a NA study. The enrollment target is 70 participants. The study started on 2019-08-20. Estimated completion is 2027-03-30.
What conditions does trial NCT03811171 study?
This clinical trial studies the following conditions: Renal Calculi, Urinary Calculi.
What interventions are being tested in trial NCT03811171?
The interventions under investigation include: Break Wave extracorporeal lithotripsy (DEVICE).
Who is sponsoring clinical trial NCT03811171?
This trial is sponsored by SonoMotion, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03811171 being conducted?
This trial has 6 study locations across California, Washington, Alberta, British Columbia, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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