Hydronephrosis Clinical Trial
— AlliumOfficial title:
Efficacy and Safety of Self-expanding Ureteral Stent for Treating Refractory Ureteral Stricture: Results of a Multicenter Experience
To conduct a prospective, multi-center study to observe the long-term efficacy and safety of self expanding ureteral stent for treating participants with refractory ureteral stricture.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | July 30, 2027 |
Est. primary completion date | July 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - refractory ureteral stricture after at least two times of ureteral dilation Exclusion Criteria: - poor cardiovascular function for anesthesia unwilling to accept the long-term placement of ureteral stent uncontrolled urinary tract infection |
Country | Name | City | State |
---|---|---|---|
Taiwan | En Chu Kong Hospital | New Taipei City |
Lead Sponsor | Collaborator |
---|---|
En Chu Kong Hospital |
Taiwan,
Avitan O, Bahouth Z, Shprits S, Gorenberg M, Halachmi S. Allium Ureteral Stent as a Treatment for Ureteral Stricture: Results and Concerns. Urol Int. 2022;106(5):482-486. doi: 10.1159/000522174. Epub 2022 Mar 1. — View Citation
Sampogna G, Grasso A, Montanari E. Expandable metallic ureteral stent: indications and results. Minerva Urol Nefrol. 2018 Jun;70(3):275-285. doi: 10.23736/S0393-2249.18.03035-7. Epub 2018 Mar 28. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Renal function test | serum creatinine (mg/dL) | 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months | |
Secondary | Complications | device associated complications (e.g. urinary tract infection, stone formation, hematuria, stent migration) | 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months | |
Secondary | Renal structure | Renal echo (e.g. no hydronephrosis, mild hydronephrosis, moderate hydronephrosis, orsevere hydronephrosis) | 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months |
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