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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04250090
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
ChungChengWang, En Chu Kong Hospital

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

Condition or disease
Ureter Stricture Hydronephrosis

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

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Post-Marketing Follow-Up of Long-term Type Ureteral Stent Set
Actual Study Start Date : July 9, 2019
Estimated Primary Completion Date : July 30, 2022
Estimated Study Completion Date : October 31, 2022

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



Primary Outcome Measures :
  1. Hydronephrosis [ Time Frame: 5 years ]
    no hydronephrosis, mild hydronephrosis, moderate hydronephrosis, severe hydronephrosis

  2. Renal function [ Time Frame: 5 years ]
    serum BUN level

  3. Renal function [ Time Frame: 5 years ]
    serum Creatine level

  4. Days of stent placement [ Time Frame: 5 years ]
    Mean days of stent placement



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250090


Contacts
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Contact: Chung Cheng Wang, MD. Ph. D 886-226723456 ext 6620 ericwcc@ms27.hinet.net

Locations
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Taiwan
En Chu Kong Hospital Recruiting
New Taipei City, Sanxia Dist., Taiwan, 23702
Contact: Chung Cheng Wang, Ph. D    886-226723456 ext 6620    ericwcc@ms27.hinet.net   
Sponsors and Collaborators
En Chu Kong Hospital
Investigators
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Principal Investigator: Chung Cheng Wang, MD. Ph. D Deputy Superintendent of Department of Education and Research
Publications of Results:

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Responsible Party: ChungChengWang, Chief of urology, En Chu Kong Hospital
ClinicalTrials.gov Identifier: NCT04250090    
Other Study ID Numbers: ECKIRB1050505
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ChungChengWang, En Chu Kong Hospital:
Ureter Stricture
Hydronephrosis
Additional relevant MeSH terms:
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Hydronephrosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases