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

Not Applicable

Active, not recruiting

• Conditions: Kidney Stone; Urolithiasis; Renal Stone
• Interventions: Device: Standard Ureteroscopy (Basketing); Device: SURE

• 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

Study Timeline

• Study First Submitted: 2020-08-17
• Study First Submitted QC: 2020-08-17
• Study First Posted: 2020-08-19
• Study Start: 2021-06-16
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22
• Primary Completion: 2025-04
• Study Completion: 2025-04

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

Arm && Interventions

Group	Intervention	Description
Standard Ureteroscopy (Basketing)	Standard Ureteroscopy (Basketing)	-
SURE	SURE	-

Primary Outcome Measures

Name	Time	Method
SFR	30 days	Stone Free Rate

Trial Locations

Locations (11)

Duke University; 🇺🇸 Durham, North Carolina, United States

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

Prisma Health; 🇺🇸 Greenville, South Carolina, United States

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Urology of Virginia; 🇺🇸 Virginia Beach, Virginia, United States

Urology Austin; 🇺🇸 Austin, Texas, United States

Dell Medical School, The University of Texas at Austin; 🇺🇸 Austin, Texas, United States