Efficacy and Safety of Allium Ureteral Stent for Treating Refractory Ureteral Stricture (Allium)
Primary Purpose
Ureteral Stenosis, Hydronephrosis, Ureteral Stent Occlusion
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Allium ureteral stent
Sponsored by
About this trial
This is an interventional treatment trial for Ureteral Stenosis focused on measuring ureteral stone, ureteral stricture, hydronephrosis
Eligibility Criteria
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
Sites / Locations
- En Chu Kong HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single arm
Arm Description
single arm without placebo control
Outcomes
Primary Outcome Measures
Renal function test
serum creatinine (mg/dL)
Secondary Outcome Measures
Complications
device associated complications (e.g. urinary tract infection, stone formation, hematuria, stent migration)
Renal structure
Renal echo (e.g. no hydronephrosis, mild hydronephrosis, moderate hydronephrosis, orsevere hydronephrosis)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05455307
Brief Title
Efficacy and Safety of Allium Ureteral Stent for Treating Refractory Ureteral Stricture
Acronym
Allium
Official Title
Efficacy and Safety of Self-expanding Ureteral Stent for Treating Refractory Ureteral Stricture: Results of a Multicenter Experience
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2022 (Anticipated)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
July 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
En Chu Kong Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureteral Stenosis, Hydronephrosis, Ureteral Stent Occlusion
Keywords
ureteral stone, ureteral stricture, hydronephrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single group without control
Masking
None (Open Label)
Masking Description
no masking
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
single arm
Arm Type
Experimental
Arm Description
single arm without placebo control
Intervention Type
Device
Intervention Name(s)
Allium ureteral stent
Intervention Description
observe the effficacy and safety of long-term self expanding ureteral stents for treating refractory ureteral stricture
Primary Outcome Measure Information:
Title
Renal function test
Description
serum creatinine (mg/dL)
Time Frame
6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months
Secondary Outcome Measure Information:
Title
Complications
Description
device associated complications (e.g. urinary tract infection, stone formation, hematuria, stent migration)
Time Frame
6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months
Title
Renal structure
Description
Renal echo (e.g. no hydronephrosis, mild hydronephrosis, moderate hydronephrosis, orsevere hydronephrosis)
Time Frame
6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chung Cheng Wang, MD PhD
Phone
886-26723456
Ext
6620
Email
ericwcc@ms27.hinet.net
First Name & Middle Initial & Last Name or Official Title & Degree
Hsin-Yi Lin, BS
Phone
886-26723456
Ext
6621
Email
hhan309@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chung Cheng Wang, MD PhD
Organizational Affiliation
En Chu Kong Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
En Chu Kong Hospital
City
New Taipei City
ZIP/Postal Code
23702
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chung Cheng Wang, MD PhD
Phone
886-26723456
Ext
6620
Email
ericwcc@ms27.hinet.net
First Name & Middle Initial & Last Name & Degree
Hsin-Yi Lin, BS
Phone
886-26723456
Ext
6621
Email
hhan309@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Other researchers can e-mail to us for data sharing
Citations:
PubMed Identifier
35231922
Citation
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.
Results Reference
result
PubMed Identifier
29595037
Citation
Sampogna 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.
Results Reference
result
Learn more about this trial
Efficacy and Safety of Allium Ureteral Stent for Treating Refractory Ureteral Stricture
We'll reach out to this number within 24 hrs