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

Not Applicable
Active, not recruiting
Conditions
Kidney Stone
Urolithiasis
Renal Stone
Registration Number
NCT04519294
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
162
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
SFR30 days

Stone Free Rate

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (11)

Mayo Clinic

🇺🇸

Phoenix, Arizona, United States

Arizona Institute of Urology

🇺🇸

Tucson, Arizona, United States

Johns Hopkins

🇺🇸

Baltimore, Maryland, United States

New Jersey Urology

🇺🇸

Voorhees, New Jersey, United States

Albany Medical College

🇺🇸

Albany, New York, United States

Duke University

🇺🇸

Durham, North Carolina, United States

Prisma Health

🇺🇸

Greenville, South Carolina, United States

Urology Austin

🇺🇸

Austin, Texas, United States

Dell Medical School, The University of Texas at Austin

🇺🇸

Austin, Texas, United States

UT Southwestern Medical Center

🇺🇸

Dallas, Texas, United States

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Mayo Clinic
🇺🇸Phoenix, Arizona, United States

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