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

En Chu Kong Hospital

Status: Unknown

Conditions: Hydronephrosis; Ureter Stricture

Study type: Observational

Funder types: Other

Identifiers

NCT04250090

ECKIRB1050505

Details and patient eligibility

About

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

Full 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

Enrollment: 20 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

Long-term type ureteral stent set

Description:

Patients with Long-term type ureteral stent set due to ureteral stricture.