150 Participants NeededMy employer runs this trial

Steerable Ureteroscopic Renal Evacuation for Kidney Stones

(TRUST Trial)

Recruiting at 4 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Calyxo, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best method for removing kidney stones using two different techniques. The first method employs standard ureteroscopy (URS), where a laser breaks the stones into small pieces. The second method, Steerable Ureteroscopic Renal Evacuation (SURE) with the CVAC System, uses a special tool to see, wash, and extract the stones. Individuals needing kidney stone removal who can attend all trial visits and procedures may be suitable candidates. As an unphased trial, this study allows patients to contribute to innovative research that could enhance kidney stone treatments.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System is safe for treating kidney stones?

A recent study found that a new method, steerable ureteroscopic renal evacuation (SURE) using the CVAC System, is safe for treating kidney stones. Research shows that this method is both safe and effective, requiring fewer doctor visits than other treatments. Studies have confirmed its safety and success in removing stones. Overall, SURE with the CVAC System appears well-tolerated, making it a promising option for those dealing with kidney stones.12345

Why are researchers excited about this trial?

Researchers are excited about the Steerable Ureteroscopic Renal Evacuation (SURE) with the CVAC System because it offers a new approach to removing kidney stones. Unlike standard ureteroscopy, which primarily uses lasers to break stones into smaller pieces, the CVAC System integrates vision, irrigation, and aspiration to directly remove stones, fragments, and dust. This method could potentially reduce the need for additional procedures and improve recovery time by efficiently clearing out stone debris. The steerable design of the CVAC System also allows for enhanced precision and control during the procedure, potentially leading to better outcomes for patients.

What evidence suggests that this trial's treatments could be effective for urolithiasis?

Research has shown that the Steerable Ureteroscopic Renal Evacuation (SURE) method, using the CVAC system, effectively removes kidney stones. Participants in this trial may receive the SURE method, which studies indicate clears stones thoroughly, leaving fewer fragments behind. This is crucial because leftover pieces can cause further issues. One study found that SURE outperformed traditional methods in completely removing stones. Overall, the CVAC system has proven to be a safe and effective treatment for kidney stones. Meanwhile, other participants in this trial will receive Standard Ureteroscopy (URS), a traditional method that uses a laser to break the stone into small pieces.12346

Are You a Good Fit for This Trial?

This trial is for people with kidney stones who are candidates for ureteroscopy with laser treatment. Participants must be able to attend follow-up visits and agree to take part after being informed about the study.

Inclusion Criteria

I am scheduled for ureteroscopy with laser treatment for kidney stones.
I can attend all required follow-up visits for the study.
I have been informed about the study and have signed the consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either Steerable Ureteroscopic Renal Evacuation (SURE) with the CVAC System or standard ureteroscopy with laser lithotripsy for the treatment of urolithiasis

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Standard Ureteroscopy (URS)
  • Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System

Trial Overview

The study compares two ways of removing kidney stones: a new method called SURE using the CVAC System, and standard ureteroscopy (URS) with laser lithotripsy. Patients are randomly assigned to one of these treatments.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Steerable Ureteroscopic Renal Evacuation (SURE) with CVAC SystemActive Control1 Intervention
Group II: Standard Ureteroscopy (URS)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Calyxo, Inc.

Lead Sponsor

Trials
2
Recruited
200+

Citations

Steerable Ureteroscopic Renal Evacuation (SURE) for Large ...

The results of a recent pilot study suggest that steerable ureteroscopic renal evacuation (SURE) is safe and more effective in stone removal than basketing ...

CLinical Evaluation of Aspiration for Removal ANd ...

The purpose of the study is to assess safety and efficacy of a novel steerable ureteral catheter system, the CVAC System for the treatment of urinary stones.

CVAC System Shows Real-World Safety, Effectiveness for ...

Steerable ureteroscopic renal evacuation (SURE) using the CVAC® system is proving to be a safe and effective treatment for renal stones.

A Prospective Study of Steerable Ureteroscopic Renal ...

The CVAC Aspiration System safely delivers high stone clearance and low RSV. Introduction. Urolithiasis is a condition of substantial burden in ...

UCSD Kidney Stones Trial → Retrospective, Multi-center Real ...

The objective of this study is observation of the safety and efficacy of subjects who underwent SURE procedure using the CVAC System or FANS for ...

MCP Steerable Ureteroscopic Renal Evacuation (SURE) ...

Steerable Ureteroscopic Renal Evacuation (SURE) procedure is considered experimental, investigational, and unproven for the removal of kidney ...