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NCT Number: NCT05455307

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

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.

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Key information

Conditions

Ureteral Stenosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hydronephrosis Kidney Diseases Male Urogenital Diseases Ureteral Diseases Ureteral Stent Occlusion Ureterolithiasis Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Allium ureteral stent

Device

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

Primary outcomes

  1. Renal function test

    Time frame: 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 outcomes

  1. Complications

    Time frame: 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)

  2. Renal structure

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Chung Cheng Wang, MD PhD

CONTACT

[email protected]

886-26723456 ext. 6620

Hsin-Yi Lin, BS

CONTACT

[email protected]

886-26723456 ext. 6621

Sponsors and collaborators

Lead sponsor

En Chu Kong Hospital

Other

Registry information

Official study title

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

Acronym: Allium

Important dates

Study start
2022
Primary completion
2024
Study completion
2027
First posted
Jul 13, 2022
Registry last updated
Jul 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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