NCT06720740

The RELIEF™ Ureteral Stent Randomized Controlled Trial

The RELIEF™ Ureteral Stent - Assessment of Retrograde Urinary Reflux

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Assessment of the backwards flow of urine from the bladder into the ureter (retrograde urine reflux) after placement of the RELIEF® Ureteral Stent using imaging of the bladder after filling it with contrast and assigning a urinary reflux grade. Randomized controlled trial for evaluation of the stent placement and the adequacy of short term drainage (defined as the presence of the stent in the ureter and the lack of surgical or standard of care double J stent to treat symptoms associated with the stent itself on the stented side during the first 48 hours).

Conditions

• Kidney Stone

Interventions

Type	Name	Description
DEVICE	RELIEF Ureteral Stent	The study intervention is placement of the RELIEF Ureteral Stent
DEVICE	Standard of Care Ureteral Stent	The control product is the Ascerta stent by Boston Scientific.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-12-06
• Last updated: 2026-02-13

Regulatory

• FDA-regulated device study