Ignite Creation Date:
2024-05-06 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05715086
Status:
RECRUITING
Last Update Posted:
2023-12-22
First Post:
2022-12-16
Brief Title:
UPURS Trial for Patient-centered Management of Symptomatic Obstructing Stones
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Upfront vs Postponed Ureteroscopy UPURS Trial for Patient-centered Management of Symptomatic Obstructing Stones
Status:
RECRUITING
Status Verified Date:
2023-12
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:
UPURS
Brief Summary:
A prospective non-blinded randomized controlled trial studying the management of symptomatic ureteral stones This study will compare upfront ureteroscopy vs observation and delayed intervention for patients presenting to the emergency department with a symptomatic ureteral stone
Detailed Description:
Management of symptomatic ureteral stones is variable across the United States due to a lack of clear patient-centered guidelines For patients who do not meet criteria for emergent stenting the decision to recommend upfront definitive treatment ureteroscopy ESWL or medical expulsion therapy is influenced by factors such as practice setting insurance status and day of the week This has resulted in health disparities and delays in care that disproportionately affect vulnerable patient populations
For patients presenting to the emergency department with a symptomatic ureteral stone investigators will randomize into Group A Upfront Ureteroscopy or Group B Delayed intervention and observation Both arms are considered standard of care for patients presenting with the above diagnosis
For patients presenting to the emergency department with a symptomatic ureteral stone investigators will randomize into Group A Upfront Ureteroscopy or Group B Delayed intervention and observation Both arms are considered standard of care for patients presenting with the above diagnosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None