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Comparison of Laser Lithotripsy With and Without Steerable Ureteroscopic Renal Evacuation (SURE)

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ClinicalTrials.gov Identifier: NCT04519294
Recruitment Status : Recruiting
First Posted : August 19, 2020
Last Update Posted : November 14, 2022
Sponsor:
Information provided by (Responsible Party):
Calyxo, Inc.

Study Description
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Brief Summary:
The purpose of the study is to compare the effects, good and/or bad, of a treatment for removing kidney stones called the SURE procedure for stone evacuation to the standard treatment using a basket for stone removal.

Condition or disease Intervention/treatment Phase
Kidney Stone Renal Stone Urolithiasis Device: SURE Device: Standard Ureteroscopy (Basketing) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Study to Evaluate the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation(SURE)Using the CVAC™ Aspiration System Compared to Basketing for the Removal of Renal Calculi Following Laser Lithotripsy
Actual Study Start Date : June 16, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: SURE Device: SURE
The SURE stone evacuation procedure is a technique intended to more easily and completely remove a kidney stone during a kidney stone treatment. The urologist first uses a laser to break the kidney stone into small pieces. Then with the SURE procedure, the pieces are gently vacuumed out of the kidney instead of retrieving the pieces one-by-one with a basket or leaving them to pass naturally in the urine. Basketing is allowed and might be used with the SURE procedure, if needed to remove some small stones.
Active Comparator: Standard Ureteroscopy (Basketing) Device: Standard Ureteroscopy (Basketing)
This is a treatment in which the urologist uses a laser to break a kidney stone into small pieces and then uses a tool called a basket to retrieve the pieces one at a time.


Outcome Measures
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Primary Outcome Measures :
  1. SFR [ Time Frame: 30 days ]
    Stone Free Rate


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Candidate for ureteroscopy with laser lithotripsy;
  • Presence of renal stone(s);
  • Be willing and able to return for all study-related follow up procedures; and,
  • Have been informed of the nature of the study, agreeing to its requirements, and have signed the IRB approved informed consent.

Exclusion Criteria:

  • BMI > 45;
  • Significant comorbidities;
  • Bladder, ureteral or kidney abnormalities;
  • Pregnant individuals; or
  • Unable to meet the treatment and follow up protocol requirements.
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): NCT04519294


Contacts
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Contact: Dori Glenn 404.445.9810 dori.glenn@calyxoinc.com

Locations
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United States, Arizona
Mayo Clinic Recruiting
Phoenix, Arizona, United States, 85054
Contact: Debra Ryan    480-342-1208    ryan.debra29@mayo.edu   
Arizona Institute of Urology Recruiting
Tucson, Arizona, United States, 85704
Contact: Andrea Navarrette    520-784-7042    andrea.navarrette@arizonauro.com   
United States, Maryland
Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: Julia Faranetta    410-502-2776    jfarane1@jhmi.edu   
United States, New Jersey
New Jersey Urology Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Kelley Mauro    856-673-1613    kmauro@njurology.com   
United States, New York
Albany Medical College Recruiting
Albany, New York, United States, 12208
Contact: Laura Davey    518-262-8579    AMCUrologyresearch@amc.edu   
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Fredrica Gallack    919-681-5557    fredrica.gallack@duke.edu   
United States, South Carolina
Prisma Health Recruiting
Greenville, South Carolina, United States, 29650
Contact: Abby Birrell    864-522-2117    abby.birrell@prismahealth.org   
United States, Texas
Urology Austin Active, not recruiting
Austin, Texas, United States, 78654
Dell Medical School, The University of Texas at Austin Recruiting
Austin, Texas, United States, 78712
Contact: Swetha Venkataraman    512-495-2201    swetha.venkataraman@austin.utexas.edu   
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Brooke Piskator    214-645-8787    brooke.piskator@utsouthwestern.edu   
United States, Virginia
Urology of Virginia Recruiting
Virginia Beach, Virginia, United States, 23462
Contact: Amy Bohannon       abohannon@urologyofva.net   
Sponsors and Collaborators
Calyxo, Inc.
More Information
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Responsible Party: Calyxo, Inc.
ClinicalTrials.gov Identifier: NCT04519294    
Other Study ID Numbers: CP00001
First Posted: August 19, 2020    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Kidney Calculi
Urolithiasis
Calculi
Pathological Conditions, Anatomical
 Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urinary Calculi