Comparison of Laser Lithotripsy With and Without Steerable Ureteroscopic Renal Evacuation (SURE)
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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: NCT04519294 |
Recruitment Status :
Recruiting
First Posted : August 19, 2020
Last Update Posted : November 14, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Kidney Stone Renal Stone Urolithiasis | Device: SURE Device: Standard Ureteroscopy (Basketing) | Not Applicable |
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 |

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. |
- SFR [ Time Frame: 30 days ]Stone Free Rate

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

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
Contact: Dori Glenn | 404.445.9810 | dori.glenn@calyxoinc.com |
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 |
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 |
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 |
Kidney Calculi Urolithiasis Calculi Pathological Conditions, Anatomical |
Nephrolithiasis Kidney Diseases Urologic Diseases Urinary Calculi |