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

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. Identifier: NCT04519294
Recruitment Status : Not yet recruiting
First Posted : August 19, 2020
Last Update Posted : August 21, 2020
Information provided by (Responsible Party):
Calyxo, Inc.

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) Phase 4

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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
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

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. Than 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.

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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (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.
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Responsible Party: Calyxo, Inc. Identifier: NCT04519294    
Other Study ID Numbers: CP00001
First Posted: August 19, 2020    Key Record Dates
Last Update Posted: August 21, 2020
Last Verified: August 2020

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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
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urinary Calculi