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

Sponsor

En Chu Kong Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05455307

Collaborator

(none)

200

Enrollment

Location

Arm

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ureteral Stenosis Hydronephrosis Ureteral Stent Occlusion	Device: Allium ureteral stent	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

single group without controlsingle group without control

Masking:

None (Open Label)

Masking Description:

no masking

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 30, 2022

Anticipated Primary Completion Date :

Jul 30, 2024

Anticipated Study Completion Date :

Jul 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: single arm single arm without placebo control	Device: Allium ureteral stent observe the effficacy and safety of long-term self expanding ureteral stents for treating refractory ureteral stricture

Arm

Intervention/Treatment

Experimental: single arm

single arm without placebo control

Device: Allium ureteral stent

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	En Chu Kong Hospital	New Taipei City		Taiwan	23702

Sponsors and Collaborators

En Chu Kong Hospital

Investigators

Principal Investigator: Chung Cheng Wang, MD PhD, En Chu Kong Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ChungChengWang, Chief of department of Urology, En Chu Kong Hospital

ClinicalTrials.gov Identifier:

NCT05455307

Other Study ID Numbers:

eck20200608

First Posted:

Jul 13, 2022

Last Update Posted:

Jul 13, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by ChungChengWang, Chief of department of Urology, En Chu Kong Hospital

ureteral stone

ureteral stricture

hydronephrosis

Additional relevant MeSH terms:

Hydronephrosis

Constriction, Pathologic

Study Results

No Results Posted as of Jul 13, 2022