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

Urolithiasis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04519294
• Other study ID #: CP00001
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 16, 2021
• Est. completion date: April 2025

Study information

• Verified date: March 2023
• Source: Calyxo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 162
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone
• Renal Stone
• Urolithiasis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Albany Medical College	Albany	New York
United States	Dell Medical School, The University of Texas at Austin	Austin	Texas
United States	Urology Austin	Austin	Texas
United States	Johns Hopkins	Baltimore	Maryland
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Duke University	Durham	North Carolina
United States	Prisma Health	Greenville	South Carolina
United States	Mayo Clinic	Phoenix	Arizona
United States	Arizona Institute of Urology	Tucson	Arizona
United States	Urology of Virginia	Virginia Beach	Virginia
United States	New Jersey Urology	Voorhees	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Calyxo, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SFR	Stone Free Rate	30 days