Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2026-01-04 @ 5:21 AM
Study NCT ID:
NCT04796792
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2021-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound to Facilitate Stone Passage
Sponsor:
University of Washington
Organization:
Study Overview
Official Title:
Ultrasound Technology to Fragment and Reposition Urinary Stones
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 has completed Phase 1. The study is currently recruiting for Phase 2b. Recruitment has not yet started for Phase 2a.
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.
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 has completed Phase 1. The study is currently recruiting for Phase 2b. Recruitment has not yet started for Phase 2a.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5P01DK043881-26 | NIH | None | https://reporter.nih.gov/quic… | View |