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Coated Metal Ureteral Stent in the Treatment of Radiation Induced Ureteral Stricture

Primary Purpose

Ureteral Stricture, Hydronephrosis, Radiation Exposure

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Coated metal ureteral stent(CMUS)
Double-J stent(DJS)
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ureteral Stricture focused on measuring radiation induced ureteral stricture, coated metal ureteral stent, safety, efficacy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Clinical diagnosis of ureteral stricture and hydronephrosis.
  2. Previous history of radiation therapy.
  3. Must be able to tolerate surgery.

Exclusion Criteria:

  1. Combine with hypertonic neurogenic bladder (except for patients with long-term indwelling catheter).
  2. Colon resection surgery patients.

Sites / Locations

  • Peiking university people's hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

CMUS group

DJS group

Arm Description

Coated metal ureteral stent is indwelled.

Double-J stent is indwelled

Outcomes

Primary Outcome Measures

Patency rate
Number of patients evaluated with hydronephrosis
Indwelling time
Number of months of the implant in the ureter
Device related serious adverse events
Number of device related serious adverse events

Secondary Outcome Measures

Full Information

First Posted
June 14, 2020
Last Updated
June 13, 2022
Sponsor
Peking University People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04441320
Brief Title
Coated Metal Ureteral Stent in the Treatment of Radiation Induced Ureteral Stricture
Official Title
Efficacy and Safety of Coated Metal Ureteral Stent in the Treatment of Radiation Induced Ureteral Stricture, A Prospective, Mutlcenter and Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A prospective, multicenter and controlled study to observe the efficacy and safety of coated metal ureteral stent in the treatment of radiation induced ureteral stricture.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureteral Stricture, Hydronephrosis, Radiation Exposure
Keywords
radiation induced ureteral stricture, coated metal ureteral stent, safety, efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CMUS group
Arm Type
Experimental
Arm Description
Coated metal ureteral stent is indwelled.
Arm Title
DJS group
Arm Type
Other
Arm Description
Double-J stent is indwelled
Intervention Type
Device
Intervention Name(s)
Coated metal ureteral stent(CMUS)
Intervention Description
Coated metal ureteral stent aims to treat the patients with refractory ureteral stricture, such as radiation induced ureteral stricture. In this study, CMUS is indwelled to observe the efficacy and safety in the treatment of radiation induced ureteral stricture compared with Double-J stent.
Intervention Type
Device
Intervention Name(s)
Double-J stent(DJS)
Intervention Description
Double-J stent is commonly used for treatment of kinds of ureteral stricture. In this study, DJS is indwelled as a controlled group.
Primary Outcome Measure Information:
Title
Patency rate
Description
Number of patients evaluated with hydronephrosis
Time Frame
Up to 36 months
Title
Indwelling time
Description
Number of months of the implant in the ureter
Time Frame
Up to 36 months
Title
Device related serious adverse events
Description
Number of device related serious adverse events
Time Frame
Up to 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of ureteral stricture and hydronephrosis. Previous history of radiation therapy. Must be able to tolerate surgery. Exclusion Criteria: Combine with hypertonic neurogenic bladder (except for patients with long-term indwelling catheter). Colon resection surgery patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mingrui Wang
Phone
19801286883
Email
wangmingrui1995@pku.edu.cn
Facility Information:
Facility Name
Peiking university people's hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingrui Wang, Doctor

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Coated Metal Ureteral Stent in the Treatment of Radiation Induced Ureteral Stricture

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