Skip to main content

Calyxo TRUST Study

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
I'm interested
Share this study

Objective

The goal of this clinical trial is to compare Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System and standard ureteroscopy (URS) with laser lithotripsy for the treatment of urolithiasis. This is a prospective, randomized (1:1), multi-center study.

Details

Full study title Evaluating the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation (SURE) with the CVAC? System Compared to Standard Ureteroscopy with no Suction for the Treatment of Renal Stones: A Prospective, Randomized Trial
Protocol number OCR50048
ClinicalTrials.gov ID NCT07101809
Phase N/A

Eligibility

Inclusion Criteria:

  • Candidate for ureteroscopy with laser lithotripsy

  • Be willing and able to return for and respond to all study-related follow up procedures

  • Have been informed of the nature of the study and has provided informed consent using the IRB approved informed consent (ICF)

Exclusion Criteria:

  • Untreated urinary tract infection at the time of the index procedure

  • Significant comorbidities

  • Bladder, ureteral or kidney abnormalities

  • Pregnant individuals

  • Unable to meet the treatment and follow up protocol requirements

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.