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

  • STATUS
    Recruiting
  • participants needed
    20
  • sponsor
    En Chu Kong Hospital
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Updated on 16 February 2024
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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

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

Details
Condition Nephropathy, Nephropathy, Hydronephrosis, Ureter Stricture
Age 20years - 100years
Clinical Study IdentifierNCT04250090
SponsorEn Chu Kong Hospital
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Patients with any of the following conditions are excluded from this clinical study
Patients with incomplete basic parameters
\. The minorities, children and special populations
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