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(352) 733-0111

DJUS Registry

  • Status
    Accepting Candidates
  • Age
    N/A - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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

Details

Full study title Boston Scientific Double-J Ureteral Stent Postmarket Patient Registry
Protocol number OCR40228
ClinicalTrials.gov ID NCT04197583

Eligibility

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

Lead researcher

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.