Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
50 participants
INTERVENTIONAL
2024-12-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Standard of Care Ureteral Stent
Standard of Care Ureteral Stent
The control product is the Ascerta stent by Boston Scientific.
RELIEF Ureteral Stent
RELIEF Ureteral Stent
The study intervention is placement of the RELIEF Ureteral Stent
Interventions
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RELIEF Ureteral Stent
The study intervention is placement of the RELIEF Ureteral Stent
Standard of Care Ureteral Stent
The control product is the Ascerta stent by Boston Scientific.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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The Ureteral Stent Company
UNKNOWN
University of California, San Diego
OTHER
Responsible Party
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Seth Bechis
Associate Professor of Urology
Principal Investigators
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Seth K Bechis, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Central Contacts
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References
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Chew BH, Knudsen BE, Denstedt JD. The use of stents in contemporary urology. Curr Opin Urol. 2004 Mar;14(2):111-5. doi: 10.1097/00042307-200403000-00011.
Joshi HB, Okeke A, Newns N, Keeley FX Jr, Timoney AG. Characterization of urinary symptoms in patients with ureteral stents. Urology. 2002 Apr;59(4):511-6. doi: 10.1016/s0090-4295(01)01644-2.
Chambade D, Thibault F, Niang L, Lakmichi MA, Gattegno B, Thibault P, Traxer O. [Study of the safety of double J ureteric stents]. Prog Urol. 2006 Sep;16(4):445-9. French.
Shao Y, Shen ZJ, Zhuo J, Liu HT, Yu SQ, Xia SJ. The influence of ureteral stent on renal pelvic pressure in vivo. Urol Res. 2009 Aug;37(4):221-5. doi: 10.1007/s00240-009-0199-z. Epub 2009 Jun 10.
Giannarini G, Keeley FX Jr, Valent F, Manassero F, Mogorovich A, Autorino R, Selli C. Predictors of morbidity in patients with indwelling ureteric stents: results of a prospective study using the validated Ureteric Stent Symptoms Questionnaire. BJU Int. 2011 Feb;107(4):648-54. doi: 10.1111/j.1464-410X.2010.09482.x.
Krebs A, Deane LA, Borin JF, Edwards RA, Sala LG, Khan F, Abdelshehid C, McDougall EM, Clayman RV. The 'buoy' stent: evaluation of a prototype indwelling ureteric stent in a porcine model. BJU Int. 2009 Jul;104(1):88-92. doi: 10.1111/j.1464-410X.2008.08338.x. Epub 2009 Jan 14.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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809792
Identifier Type: -
Identifier Source: org_study_id