SURE vs. Standard Ureteroscopy for Kidney Stones

Recruiting at 10 trial locations

Overseen By Dori Glenn

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Calyxo, Inc.

Disqualifiers: Bmi > 45, Significant comorbidities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

162 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is comparing a new method called the SURE procedure for removing kidney stones to the traditional basket method. It aims to see which method works better and has fewer side effects for patients who need kidney stone removal.

Eligibility Criteria

This trial is for individuals who need treatment for kidney stones and are candidates for a procedure called ureteroscopy with laser lithotripsy. Participants must be able to attend all follow-up procedures, understand the study, and have signed consent. It's not open to pregnant people, those with a BMI over 45, significant other health issues, or abnormalities in the bladder, ureter or kidneys.

Inclusion Criteria

I have kidney stones.

I am a candidate for a procedure to remove kidney stones using lasers.

Have been informed of the nature of the study, agreeing to its requirements, and have signed the IRB approved informed consent.

Exclusion Criteria

I have issues with my bladder, ureter, or kidneys.

Unable to meet the treatment and follow up protocol requirements.

You have other serious health problems.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either the SURE procedure or standard basketing for kidney stone removal

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on Stone Free Rate

4 weeks

Treatment Details

Interventions

• Standard Ureteroscopy
• SURE

Trial Overview The study compares two methods of removing kidney stones: SURE (Steerable Ureteroscopic Renal Evacuation) versus standard basketing during ureteroscopy. The goal is to determine which method has better outcomes for patients.

Participant Groups

Group I: Standard Ureteroscopy (Basketing) Active Control 1 Intervention

Group II: SURE Active Control 1 Intervention

Who Is Running the Clinical Trial?

Calyxo, Inc.

Lead Sponsor

Trials

2

Recruited

200+