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

Not Applicable

Recruiting

• Conditions: Hydronephrosis; Ureteral Stent Occlusion; Ureteral Stenosis
• Interventions: Device: Allium ureteral stent

• Registration Number: NCT05455307
• Lead Sponsor: En Chu Kong Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-06-08
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-07
• Last Update Submitted: 2022-07-07
• Study First Posted: 2022-07-13
• Last Update Posted: 2022-07-13
• Study Start: 2022-07-30
• Primary Completion: 2024-07-30
• Study Completion: 2027-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• refractory ureteral stricture after at least two times of ureteral dilation

Read More

Exclusion Criteria

• poor cardiovascular function for anesthesia unwilling to accept the long-term placement of ureteral stent uncontrolled urinary tract infection

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm	Allium ureteral stent	single arm without placebo control

Primary Outcome Measures

Name	Time	Method
Renal function test	6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months	serum creatinine (mg/dL)

Secondary Outcome Measures

Name	Time	Method
Renal structure	6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months	Renal echo (e.g. no hydronephrosis, mild hydronephrosis, moderate hydronephrosis, orsevere hydronephrosis)
Complications	6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months	device associated complications (e.g. urinary tract infection, stone formation, hematuria, stent migration)

Trial Locations

Locations (1)

En Chu Kong Hospital; 🇨🇳 New Taipei City, Taiwan