Efficacy and Safety of Allium Ureteral Stent for Treating Refractory Ureteral Stricture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorEn Chu Kong Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
refractory ureteral stricture after at least two times of ureteral dilation
Disqualifiers
poor cardiovascular function for anesthesia unwilling to accept the long-term placement of ureteral stent uncontrolled urinary tract infection
Trial design
Design model
Single group
Treatments tested in this trial
Allium ureteral stent
Deviceobserve the effficacy and safety of long-term self expanding ureteral stents for treating refractory ureteral stricture
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: single armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 months2
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov