| NCT ID | NCT04796792 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Washington |
| Condition | Urinary Stone |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2023-04-01 |
| Primary Completion | 2028-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2023-04-01 with a primary completion date of 2028-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Jonathan Harper, MD
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT04796792 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Urinary Stone. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04796792 currently recruiting?
Yes, NCT04796792 is actively recruiting participants. Contact the research team at mbailey@uw.edu for enrollment information.
Where is the NCT04796792 trial being conducted?
This trial is being conducted at Carmel, United States, Seattle, United States, Seattle, United States.
Who is sponsoring the NCT04796792 clinical trial?
NCT04796792 is sponsored by University of Washington. The principal investigator is Jonathan Harper, MD at University of Washington. The trial plans to enroll 140 participants.