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Status unknownNCT04441320Updated Jun 16, 2022

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

An interventional study of Coated metal ureteral stent(CMUS) and Double-J stent(DJS) in Ureteral Stricture, Hydronephrosis and Radiation Exposure, sponsored by Peking University People's Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-06-16.

Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Ureteral Stricture
  • Hydronephrosis
  • Radiation Exposure

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Keywords

  • radiation induced ureteral stricture
  • coated metal ureteral stent
  • safety
  • efficacy
03

In context

Hydronephrosis

55 studies on the registry are indexed under Hydronephrosis; 9 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 23 interventional studies indexed under Hydronephrosis.

Browse Hydronephrosis studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 609 studies on the registry; 247 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Combine with hypertonic neurogenic bladder (except for patients with long-term indwelling catheter).
  2. Colon resection surgery patients.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    CMUS group

    Coated metal ureteral stent is indwelled.

    Device: Coated metal ureteral stent(CMUS)

  • Other
    DJS group

    Double-J stent is indwelled

    Device: Double-J stent(DJS)

Interventions

  • DeviceCoated metal ureteral stent(CMUS)

    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.

  • DeviceDouble-J stent(DJS)

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

06

What researchers measure

Primary outcomes

  1. Patency rate

    Number of patients evaluated with hydronephrosis

    Time frame: Up to 36 months

  2. Indwelling time

    Number of months of the implant in the ureter

    Time frame: Up to 36 months

  3. Device related serious adverse events

    Number of device related serious adverse events

    Time frame: Up to 36 months

07

Study locations

1 of 1 sites recruiting
  • Peiking university people's hospital
    Beijing, Beijing 100044, China
    Recruiting
    • Mingrui Wang, Doctor · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2021 (actual). Primary completion is estimated for Jul 2024, 42 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 14, 2020
First posted
Jun 22, 2020
StartActual
Jan 1, 2021
Primary completionEst.
Jul 1, 2024
CompletionEst.
Dec 31, 2024
Last update
Jun 16, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04441320
Lead sponsor
Peking University People's Hospital
Responsible party
Huhao (Associate Professor, Peking University People's Hospital) — Principal investigator
First posted
Jun 22, 2020
Start date
Jan 1, 2021
Primary completion
Jul 1, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Jun 16, 2022

Study contacts

Mingrui Wang
Contact
wangmingrui1995@pku.edu.cn
19801286883

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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