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

February 7, 2020 updated by: ChungChengWang, En Chu Kong Hospital
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

Study Overview

Status

Unknown

Conditions

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

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Sanxia Dist.
      • New Taipei City, Sanxia Dist., Taiwan, 23702
        • Recruiting
        • En Chu Kong Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

En Chu Kong Hospital

Investigators

  • Principal Investigator: Chung Cheng Wang, MD. Ph. D, Deputy Superintendent of Department of Education and Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2019

Primary Completion (Anticipated)

July 30, 2022

Study Completion (Anticipated)

October 31, 2022

Study Registration Dates

First Submitted

January 17, 2020

First Submitted That Met QC Criteria

January 29, 2020

First Posted (Actual)

January 31, 2020

Study Record Updates

Last Update Posted (Actual)

February 11, 2020

Last Update Submitted That Met QC Criteria

February 7, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECKIRB1050505

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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