NCT04441320

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 16, 2022

Status Verified

June 1, 2022

Enrollment Period

3.5 years

First QC Date

June 14, 2020

Last Update Submit

June 13, 2022

Conditions

Ureteral StrictureHydronephrosisRadiation Exposure

Keywords

radiation induced ureteral stricturecoated metal ureteral stentsafetyefficacy

Outcome Measures

Primary Outcomes (3)

  • Patency rate

    Number of patients evaluated with hydronephrosis

    Up to 36 months

  • Indwelling time

    Number of months of the implant in the ureter

    Up to 36 months

  • Device related serious adverse events

    Number of device related serious adverse events

    Up to 36 months

Study Arms (2)

CMUS group

EXPERIMENTAL

Coated metal ureteral stent is indwelled.

Device: Coated metal ureteral stent(CMUS)

DJS group

OTHER

Double-J stent is indwelled

Device: Double-J stent(DJS)

Interventions

Coated metal ureteral stent(CMUS)DEVICE

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.

CMUS group
Double-J stent(DJS)DEVICE

Double-J stent is commonly used for treatment of kinds of ureteral stricture. In this study, DJS is indwelled as a controlled group.

DJS group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peiking university people's hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Hydronephrosis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Mingrui Wang

CONTACT

19801286883wangmingrui1995@pku.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 14, 2020

First Posted

June 22, 2020

Study Start

January 1, 2021

Primary Completion

July 1, 2024

Study Completion

December 31, 2024

Last Updated

June 16, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)