An interventional study of Allium ureteral stent in Ureteral Stenosis, Hydronephrosis and Ureteral Stent Occlusion, sponsored by En Chu Kong Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-07-13.
Sponsored by En Chu Kong Hospital · Not applicable, Interventional, and Treatment
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.
The aim of the study is 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.
About 200 participants with refractory ureteral stricture will be enrolled in four hospitals. After the allium ureteral stents are placed, renal function, renal echo, images and associated complications will be recorded.
55 studies on the registry are indexed under Hydronephrosis; 9 are open to participants now.
This study's planned enrollment of 200 is above the median of 100 across 23 interventional studies indexed under Hydronephrosis.
Browse Hydronephrosis studies →En Chu Kong Hospital is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
single arm without placebo control
Device: Allium ureteral stent
observe the effficacy and safety of long-term self expanding ureteral stents for treating refractory ureteral stricture
Renal function test
serum creatinine (mg/dL)
Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months
Complications
device associated complications (e.g. urinary tract infection, stone formation, hematuria, stent migration)
Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months
Renal structure
Renal echo (e.g. no hydronephrosis, mild hydronephrosis, moderate hydronephrosis, orsevere hydronephrosis)
Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months
Plan to share: No — Other researchers can e-mail to us for data sharing
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En Chu Kong Hospital