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

Radiation Exposure Clinical Trial

Official title:

Efficacy and Safety of Coated Metal Ureteral Stent in the Treatment of Radiation Induced Ureteral Stricture, A Prospective, Mutlcenter and Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04441320
• Other study ID #: URO-02
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2022
• Source: Peking University People's Hospital
• Contact: Mingrui Wang
• Phone: 19801286883
• Email: wangmingrui1995[@]pku.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Hydronephrosis
• Radiation Exposure
• Ureteral Stricture

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
China	Peiking university people's hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patency rate	Number of patients evaluated with hydronephrosis	Up to 36 months
Primary	Indwelling time	Number of months of the implant in the ureter	Up to 36 months
Primary	Device related serious adverse events	Number of device related serious adverse events	Up to 36 months