Ureteral StrictureNCT04441320
Coated Metal Ureteral Stent in the Treatment of Radiation Induced Ureteral Stricture
A study testing Coated metal ureteral stent(CMUS) and Double-J stent(DJS) in people with Ureteral Stricture and Hydronephrosis, run by Peking University People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ureteral Stricture, Hydronephrosis, Radiation Exposure
- What is being tested?
- Coated metal ureteral stent(CMUS) and Double-J stent(DJS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of ureteral stricture and hydronephrosis.
- Previous history of radiation therapy.
- Must be able to tolerate surgery.
Who cannot join
- Combine with hypertonic neurogenic bladder (except for patients with long-term indwelling catheter).
- Colon resection surgery patients.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peiking university people's hospital
Beijing, Beijing Municipality, 100044
Mingrui Wang, Doctor
About this study
Official title: Efficacy and Safety of Coated Metal Ureteral Stent in the Treatment of Radiation Induced Ureteral Stricture, A Prospective, Mutlcenter and Controlled Study
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.
- Conditions
- Ureteral Stricture, Hydronephrosis, Radiation Exposure
- Being tested
- Coated metal ureteral stent(CMUS), Double-J stent(DJS)
- Keywords
- radiation induced ureteral stricture, coated metal ureteral stent, safety, efficacy
- Medical subject headings
- Hydronephrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| CMUS group | Experimental | Coated metal ureteral stent is indwelled. Receives: Device: Coated metal ureteral stent(CMUS) |
| DJS group | Other | Double-J stent is indwelled Receives: Device: Double-J stent(DJS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patency rate
Number of patients evaluated with hydronephrosis
Measured: Up to 36 months
Indwelling time
Number of months of the implant in the ureter
Measured: Up to 36 months
Device related serious adverse events
Number of device related serious adverse events
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Jan 2021
- Primary completion1 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral StrictureStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huhao, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441320
- Sponsor's protocol ID
- URO-02
- Status last verified
- Jun 2022
- First submitted
- 14 Jun 2020
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Coated Metal Ureteral Stent in the Treatment of Radiation Induced Ureteral Stricture, A Prospective, Mutlcenter and Controlled Study
- ClinicalTrials.gov ID
- NCT04441320
- Acronym / sponsor ID
- URO-02
- Conditions
- Ureteral Stricture, Hydronephrosis, Radiation Exposure
- Keywords
- radiation induced ureteral stricture, coated metal ureteral stent, safety, efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CMUS group | Experimental | Device: Coated metal ureteral stent(CMUS)Coated metal ureteral stent is indwelled. |
| DJS group | Other | Device: Double-J stent(DJS)Double-J stent is indwelled |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of ureteral stricture and hydronephrosis.
- Previous history of radiation therapy.
- Must be able to tolerate surgery.
Key exclusion criteria (2 listed)
- Combine with hypertonic neurogenic bladder (except for patients with long-term indwelling catheter).
- Colon resection surgery patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coated 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. | Device | CMUS group |
| Double-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. | Device | DJS group |
Primary outcome
Patency rate
Time frame: Up to 36 months
Number of patients evaluated with hydronephrosis
Indwelling time
Time frame: Up to 36 months
Number of months of the implant in the ureter
Device related serious adverse events
Time frame: Up to 36 months
Number of device related serious adverse events
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coated metal ureteral stent(CMUS) and Double-J stent(DJS) in people with Ureteral Stricture and Hydronephrosis, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mingrui Wang (19801286883, wangmingrui1995@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patency rate (time frame: Up to 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.