Clinical trial NCT04250090: Post-Marketing Follow-Up of Long-term Type Ureteral Stent Set
Official title: Post-Marketing Follow-Up of Long-term Type Ureteral Stent Set
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ureter Stricture
Hydronephrosis
Keywords: Ureter Stricture
Hydronephrosis
Lead sponsor: En Chu Kong Hospital
Sponsor class: OTHER
First posted: 2020-01-31
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The most recent patients who actually used the " Bioteq" Ureteral Stent Set (Long-Term Type) are included, and a non-grouping method is adopted

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

Eligibility criteria: Inclusion Criteria:

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

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

Primary outcomes:
measure: Hydronephrosis
timeFrame: 5 years
measure: Renal function
timeFrame: 5 years
measure: Renal function
timeFrame: 5 years
measure: Days of stent placement
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: En Chu Kong Hospital
state: Sanxia Dist.
Study officials:
affiliation: Deputy Superintendent of Department of Education and Research
name: Chung Cheng Wang, MD. Ph. D
role: PRINCIPAL_INVESTIGATOR
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