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

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05455307

Acronym

Allium

Enrollment

200

Registered

2022-07-13

Start date

2022-07-30

Completion date

2027-07-30

Last updated

2022-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hydronephrosis, Ureteral Stenosis, Ureteral Stent Occlusion

Keywords

ureteral stone, ureteral stricture, hydronephrosis

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.

Interventions

DEVICEAllium ureteral stent

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Masking description

no masking

Intervention model description

single group without control

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)
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)

Countries

Taiwan

Contacts

Primary ContactChung Cheng Wang, MD PhD

ericwcc@ms27.hinet.net886-26723456

Backup ContactHsin-Yi Lin, BS

hhan309@gmail.com886-26723456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026