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

En Chu Kong Hospital

Status: Enrolling

Conditions: Hydronephrosis; Ureteral Stenosis; Ureteral Stent Occlusion

Treatments: Device: Allium ureteral stent

Study type: Interventional

Funder types: Other

Identifiers

NCT05455307

eck20200608

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

single arm

Experimental group

Description:

single arm without placebo control

Treatment:

Device: Allium ureteral stent