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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04250090

Enrollment

Registered

2020-01-31

Start date

2019-07-09

Completion date

2022-10-31

Last updated

2020-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hydronephrosis, Ureter Stricture

Keywords

Ureter Stricture, Hydronephrosis

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Hydronephrosis	5 years	no hydronephrosis, mild hydronephrosis, moderate hydronephrosis, severe hydronephrosis
Renal function	5 years	serum BUN level
Days of stent placement	5 years	Mean days of stent placement

Countries

Taiwan

Contacts

Primary ContactChung Cheng Wang, MD. Ph. D

ericwcc@ms27.hinet.net886-226723456

Outcome results