Allium Ureteral Stent as a Treatment for Ureteral Stricture: Results and Concerns.
Ofir Avitan, Zaher Bahouth, Sagi Shprits...
https://pubmed.ncbi.nlm.nih.gov/35231922Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID05455307
Efficacy and Safety of Self-expanding Ureteral Stent for Treating Refractory Ureteral Stricture: Results of a Multicenter Experience
Led by En Chu Kong Hospital · Updated on 2022-07-13
200
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a prospective, multi-center study to observe the long-term safety and effectiveness of a self-expanding ureteral stent for treating people with refractory ureteral stricture. This condition involves persistent narrowing of the ureter that has not improved after at least two dilation procedures. The study aims to provide important insights into how well this ureteral stent works over time and its safety profile. Participants will receive the Allium ureteral stent, which is designed to expand and support the ureter, helping to relieve narrowing. This is a single-arm study without a placebo group, involving about 200 participants across four hospitals. After placement of the stent, the study will monitor kidney function, kidney ultrasound images, and any complications that arise. During the study, participants will have regular tests to evaluate kidney function and structure at intervals of 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months. Researchers will also track any complications related to the stent over this five-year period. The study will help determine the long-term outcomes and safety of this treatment for refractory ureteral stricture.
CONDITIONS
Brief Title
Efficacy and Safety of Allium Ureteral Stent for Treating Refractory Ureteral Stricture
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Diagnosis of refractory ureteral stricture after at least two ureteral dilation procedures
You will not qualify if you...
- Poor cardiovascular function making anesthesia unsafe
- Uncontrolled urinary tract infection
AI-Screening
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Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Implementation
Duration - Long-term duration following stent placement
Participants have the Allium self-expanding ureteral stent placed to treat refractory ureteral stricture.
1 visit for stent placement (in-person)
Long-term Monitoring
Duration - Up to 60 months
Participants are observed over several years to assess renal function, renal structure, and potential complications associated with the stent.
Follow-up visits approximately every 6 months for up to 10 visits
Trial Site Locations
Total: 1 location
1
En Chu Kong Hospital
New Taipei City, Taiwan, 23702
Actively Recruiting
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Research Team
C
Chung Cheng Wang, MD PhD
H
Hsin-Yi Lin, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Expandable metallic ureteral stent: indications and results.
Gianluca Sampogna, Angelica Grasso, Emanuele Montanari
https://pubmed.ncbi.nlm.nih.gov/29595037