Post-Marketing Follow-Up of Long-term Type Ureteral Stent Set

• Conditions: Hydronephrosis; Ureter Stricture

• Registration Number: NCT04250090
• Lead Sponsor: En Chu Kong Hospital

Brief Summary

Ureteral stents have been widely used in many urological operations. Although there are several reports regarding the effectiveness of long-term ureteral stents for malignancy ureteral obstruction, ureteral stricture and urolithiasis, the experience is limited about the long-term ureteral stents made by Taiwan. The investigators have to propose the 5-year post-market survey report. Though this observation study, The investigators can further understand the clinical safety and effectiveness of placing ureteral stents

Detailed Description

Ureteral stents have been widely used in many urological operations. The main purposes of placing ureteral stents include improvement of ureteral obstruction, protecting renal function and drainage of infection. Although there are several reports regarding the effectiveness of long-term ureteral stents for malignancy ureteral obstruction, ureteral stricture and urolithiasis, the experience is limited about the long-term ureteral stents made by Taiwan. Thus, The investigators will conduct this post-marketing survey to observe and investigate the changes of ureteral stents, e.g. hydronephrosis, infection and stone formation. Now this product has been approved by European Medical Device Administration. The investigators have to propose the 5-year post-market survey report. Though this observation study, The investigators can further understand the clinical safety and effectiveness of placing ureteral stents

Study Timeline

• Study Start: 2019-07-09
• Study First Submitted: 2020-01-17
• Study First Submitted QC: 2020-01-29
• Study First Posted: 2020-01-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-07
• Last Update Posted: 2020-02-11
• Primary Completion: 2022-07-30
• Study Completion: 2022-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Patients who used " Bioteq" Ureteral Stent Set (Long-Term Type) in their treatments.
2. Patients with complete basic parameters.

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Exclusion Criteria

1. Patients with any of the following conditions are excluded from this clinical study:

   Patients with incomplete basic parameters.

2. The minorities, children and special populations

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hydronephrosis	5 years	no hydronephrosis, mild hydronephrosis, moderate hydronephrosis, severe hydronephrosis
Renal function	5 years	serum Creatine level
Days of stent placement	5 years	Mean days of stent placement

Trial Locations

Locations (1)

En Chu Kong Hospital; 🇨🇳 New Taipei City, Sanxia Dist., Taiwan