What side effects are associated with this type of intervention?

Common treatments for kidney stones, such as laser lithotripsy and basket extraction, can have several side effects. Laser lithotripsy may cause bleeding, infection, and injury to the urinary tract. Basket extraction can lead to ureteral injury, infection, and residual stone fragments. Both procedures may result in discomfort, hematuria (blood in urine), and the need for additional treatments if stones are not completely removed.

What prior FDA approvals exist?

FDA-approved treatments for kidney stones include various methods such as ureteroscopy, which involves using a scope to remove stones, and extracorporeal shockwave lithotripsy (ESWL), which uses shock waves to break stones into smaller pieces that can be passed naturally. The SURE procedure, which is being studied for its efficacy in stone evacuation, is similar to these established methods. Other treatments include percutaneous nephrolithotomy for larger stones and medications to manage pain and facilitate stone passage.

What other types of research exist?

Promising, novel alternatives to the SURE procedure for kidney stone treatment in 2024 include laser lithotripsy with advanced techniques like the use of high-power lasers and digital ureteroscopy, which offer improved precision and efficacy. Additionally, minimally invasive procedures such as percutaneous nephrolithotomy (PCNL) and advancements in extracorporeal shock wave lithotripsy (ESWL) continue to evolve, providing effective options for stone removal with reduced recovery times.

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Procedure

SURE vs. Standard Ureteroscopy for Kidney Stones

N/A

Waitlist Available

Research Sponsored by Calyxo, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of renal stone(s)

Candidate for ureteroscopy with laser lithotripsy

Must not have

Bladder, ureteral or kidney abnormalities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort or pain from the procedure, bleeding, infection risk due to stone removal process and possible damage to urinary tract structures during intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have kidney stones.

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

SFR

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Standard Ureteroscopy (Basketing)Active Control1 Intervention

Group II: SUREActive Control1 Intervention

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The SURE procedure and similar stone evacuation techniques, such as laser lithotripsy, work by breaking kidney stones into smaller fragments that can be more easily passed or extracted. Laser lithotripsy uses focused laser energy to fragment the stones, while the steerable ureteroscopic renal evacuation system allows for precise targeting and removal of these fragments. This approach minimizes tissue damage and enhances the efficiency of stone removal, which is important for patients to reduce complications and improve recovery outcomes.

Metabolic risk-evaluation and prevention of recurrence in stone disease: does it make sense?New concepts in shock wave lithotripsy.