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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05455307
Other study ID # eck20200608
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 30, 2022
Est. completion date July 30, 2027

Study information

Verified date July 2022
Source En Chu Kong Hospital
Contact Chung Cheng Wang, MD PhD
Phone 886-26723456
Email ericwcc@ms27.hinet.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Intervention

Device:
Allium ureteral stent
observe the effficacy and safety of long-term self expanding ureteral stents for treating refractory ureteral stricture

Locations

Country Name City State
Taiwan En Chu Kong Hospital New Taipei City

Sponsors (1)

Lead Sponsor Collaborator
En Chu Kong Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

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

Outcome

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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