The RELIEF™ Ureteral Stent Randomized Controlled Trial

University of California San Diego

Status: Not yet enrolling

Conditions: Kidney Stone

Treatments: Device: RELIEF Ureteral Stent; Device: Standard of Care Ureteral Stent

Study type: Interventional

Funder types: Other

Identifiers

NCT06720740

809792

Details and patient eligibility

About

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).

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Has capacity to consent
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Persons, 18 years of age or older
• Male or female subjects with confirmed ureteral and/or renal stones or strictures documented via abdomen X-ray KUB (kidney ureter bladder) or CT (computed tomography)

Exclusion criteria

• Distal ureteral obstruction where suture portion of stent may be placed
• Urinary reflux (assessed by pre-stent cystogram)
• Pregnancy or lactation
• Patients requiring bilateral surgical stone management procedure
• Infected stones
• Patients where 24cm or 26cm stent lengths are not suitable
• Ureteral structure in distal third of ureter
• Intraoperative exclusion: based on urologist's discretion, if trauma has been induced to the distal ureter due to ureteroscopy maneuvers, exclude these patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Standard of Care Ureteral Stent

Active Comparator group

Treatment:

Device: Standard of Care Ureteral Stent

RELIEF Ureteral Stent

Experimental group

Treatment:

Device: RELIEF Ureteral Stent