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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CMUS group | Experimental | Coated metal ureteral stent is indwelled. |
|
| DJS group | Other | Double-J stent is indwelled |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingrui Wang | Contact | 19801286883 | wangmingrui1995@pku.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peiking university people's hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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| ID | Term |
|---|---|
| D006869 | Hydronephrosis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 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. |
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |