Efficacy and Safety of Allium Ureteral Stent for Treating Refractory Ureteral Stricture
Allium
Efficacy and Safety of Self-expanding Ureteral Stent for Treating Refractory Ureteral Stricture: Results of a Multicenter Experience
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2022
CompletedFirst Posted
Study publicly available on registry
July 13, 2022
CompletedStudy Start
First participant enrolled
July 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2027
ExpectedJuly 13, 2022
July 1, 2022
2 years
June 8, 2022
July 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Renal function test
serum creatinine (mg/dL)
6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months
Secondary Outcomes (2)
Complications
6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months
Renal structure
6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months
Study Arms (1)
single arm
EXPERIMENTALsingle arm without placebo control
Interventions
observe the effficacy and safety of long-term self expanding ureteral stents for treating refractory ureteral stricture
Eligibility Criteria
You may qualify if:
- refractory ureteral stricture after at least two times of ureteral dilation
You may not qualify if:
- poor cardiovascular function for anesthesia unwilling to accept the long-term placement of ureteral stent uncontrolled urinary tract infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
En Chu Kong Hospital
New Taipei City, 23702, Taiwan
Related Publications (2)
Avitan O, Bahouth Z, Shprits S, Gorenberg M, Halachmi S. Allium Ureteral Stent as a Treatment for Ureteral Stricture: Results and Concerns. Urol Int. 2022;106(5):482-486. doi: 10.1159/000522174. Epub 2022 Mar 1.
PMID: 35231922RESULTSampogna G, Grasso A, Montanari E. Expandable metallic ureteral stent: indications and results. Minerva Urol Nefrol. 2018 Jun;70(3):275-285. doi: 10.23736/S0393-2249.18.03035-7. Epub 2018 Mar 28.
PMID: 29595037RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chung Cheng Wang, MD PhD
En Chu Kong Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- no masking
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of department of Urology
Study Record Dates
First Submitted
June 8, 2022
First Posted
July 13, 2022
Study Start
July 30, 2022
Primary Completion
July 30, 2024
Study Completion (Estimated)
July 30, 2027
Last Updated
July 13, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share
Other researchers can e-mail to us for data sharing