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

NCT ID: NCT05455307

Last Updated: 2022-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-30

Study Completion Date

2027-07-30

Brief Summary

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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

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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.

Conditions

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Ureteral Stenosis Hydronephrosis Ureteral Stent Occlusion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

single group without control
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

no masking

Study Groups

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single arm

single arm without placebo control

Group Type EXPERIMENTAL

Allium ureteral stent

Intervention Type DEVICE

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

Interventions

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Allium ureteral stent

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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En Chu Kong Hospital

OTHER

Sponsor Role lead

Responsible Party

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ChungChengWang

Chief of department of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chung Cheng Wang, MD PhD

Role: PRINCIPAL_INVESTIGATOR

En Chu Kong Hospital

Locations

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En Chu Kong Hospital

New Taipei City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chung Cheng Wang, MD PhD

Role: CONTACT

886-26723456 ext. 6620

Hsin-Yi Lin, BS

Role: CONTACT

886-26723456 ext. 6621

Facility Contacts

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Chung Cheng Wang, MD PhD

Role: primary

886-26723456 ext. 6620

Hsin-Yi Lin, BS

Role: backup

886-26723456 ext. 6621

References

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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.

Reference Type RESULT
PMID: 35231922 (View on PubMed)

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.

Reference Type RESULT
PMID: 29595037 (View on PubMed)

Other Identifiers

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eck20200608

Identifier Type: -

Identifier Source: org_study_id

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