Efficacy and Safety of Allium Ureteral Stent for Treating Refractory Ureteral Stricture

Hydronephrosis Clinical Trial

— Allium  

Official title:

Efficacy and Safety of Self-expanding Ureteral Stent for Treating Refractory Ureteral Stricture: Results of a Multicenter Experience

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05455307
• Other study ID #: eck20200608
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Hydronephrosis
• Ureteral Stent Occlusion

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