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Double-J PLUS Postmarket Registry

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04197583
Recruitment Status : Completed
First Posted : December 13, 2019
Last Update Posted : May 16, 2023
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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Brief Summary:
A multi-center global registry to obtain post-market safety and efficacy data on Boston Scientific Ureteral and Urinary Diversion Stents

Condition or disease Intervention/treatment
Ureter Obstruction Device: Boston Scientific Ureteral Stents, Urinary Diversion Stent

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 379 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 15 Months
Official Title: Boston Scientific Double-J PLUS Ureteral Stent Postmarket Patient Registry
Actual Study Start Date : February 19, 2020
Actual Primary Completion Date : January 16, 2023
Actual Study Completion Date : February 22, 2023
Groups and Cohorts
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Intervention Details:
  • Device: Boston Scientific Ureteral Stents, Urinary Diversion Stent
    A BSC Ureteral Stent is an implantable device that is used to restore flow of urine from the kidney to the bladder in obstructed ureters. A BSC Urinary Diversion Stent is an implantable device that is used to restore flow of urine from the kidney.

Outcome Measures
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Primary Outcome Measures :
  1. Technical Success [ Time Frame: 2 months to 12 Months ]
    For all stents other than Urinary Diversion Stents: Stented kidney drains (to bladder) during the planned indwell time with no re-intervention due to obstruction of the stented ureters. For Urinary Diversion Stent, drainage from the kidney following stent placement during the planned indwell time with no re-intervention for obstruction.

  2. Primary safety endpoint [ Time Frame: 2 months to 12 Months ]
    Any Serious Adverse Device Effects


Secondary Outcome Measures :
  1. Quality of Life - Patient-Reported Outcomes [ Time Frame: 2 months, 12 Months ]

    Measurement System (PROMIS®) for subjects ≥18 years

    • PROMIS Adult Short Form v1.0 - Pain Intensity 3a
    • PROMIS Adult Short Form v1.0 - Pain Interference 6b

  2. Stent Migration [ Time Frame: 2 months to 12 Months ]
    Stent Migration: Confirmed via imaging


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Study will enroll patients who are receiving a Boston Scientific Ureteral stent or Urinary Diversion Stent as part of their standard of care.
Criteria

Inclusion Criteria (for all Ureteral stent types except Urinary Diversion Stents):

  • Subject is undergoing placement of a Boston Scientific Ureteral Stent
  • Subject anatomy is appropriate to accommodate a stent size available in the study
  • Subject is able to accurately detect and report bladder function and pain

  • Subject is willing and able to:

    • Complete patient QoL questionnaire at specified time points (for subjects aged ≥ 18 years)
    • Return for all follow-up visits

Inclusion Criteria (for Urinary Diversion Stents):

  • Subject is undergoing placement of a Boston Scientific Urinary Diversion Stent(s)
  • The anatomical features of the involved renal collecting system are known by either prior or concurrent urography or axial CT imaging
  • Subject is willing and able to return for all follow-up visits

Exclusion Criteria (for Ureteral stents and Urinary Diversion Stents):

  • Subjects who meet any of the contraindications per individual stent DFU
  • Subjects receiving different stent type in case of bilateral/multiple stenting
  • Subjects with an indwelling ureteral stent(s) not planned to be removed prior to/or concurrently with the study stent implant
Contacts and Locations
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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): NCT04197583


Locations
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United States, Arizona
Mayo Clinic Phoenix
Phoenix, Arizona, United States, 85054
United States, Illinois
Northwestern University-Department of Urology
Chicago, Illinois, United States, 60611
NorthShore University HealthSystem
Glenview, Illinois, United States, 60026
United States, Indiana
Indiana University Health
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, New York
New York Presbyterian Hospital-Columbia University Medical Center
New York, New York, United States, 10032
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
France
Centre Hospit Prive St Gregoire Vivalto
St Gregoire, France, 35760
Japan
Nagoya City University Hospital
Nagoya City, Aichi, Japan, 467-8602
Sponsors and Collaborators
Boston Scientific Corporation
More Information
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT04197583    
Other Study ID Numbers: U0652
First Posted: December 13, 2019    Key Record Dates
Last Update Posted: May 16, 2023
Last Verified: May 2023
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: Yes
Additional relevant MeSH terms:
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Ureteral Obstruction
Ureteral Diseases
Urologic Diseases
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases