Post-Marketing Follow-Up of Long-term Type Ureteral Stent Set
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ureter Stricture
- Sponsor
- En Chu Kong Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Hydronephrosis
- Last Updated
- 6 years ago
Overview
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
Investigators
ChungChengWang
Chief of urology
En Chu Kong Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Hydronephrosis
Time Frame: 5 years
no hydronephrosis, mild hydronephrosis, moderate hydronephrosis, severe hydronephrosis
Renal function
Time Frame: 5 years
serum Creatine level
Days of stent placement
Time Frame: 5 years
Mean days of stent placement