The RELIEF™ Ureteral Stent Randomized Controlled Trial
NCT06720740 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2026-02-13
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
- 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.
Sponsors & Collaborators
-
The Ureteral Stent Company
collaborator UNKNOWN -
University of California, San Diego
lead OTHER
Principal Investigators
-
Seth K Bechis, MD · University of California, San Diego
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-12-01
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
- FDA Device
- Yes
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