FANS vs CVAC for Kidney Stones

ML
Overseen ByMatthew Lee, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ohio State University
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 compares two new devices, FANS and CVAC, used in procedures to remove kidney stones. Both devices are ureteroscopes, which help doctors see and remove stones from the urinary tract, but they employ different suction technologies. The trial aims to determine which device more effectively achieves a stone-free status for patients. Individuals with kidney stones measuring 8-20 mm and diagnosed with nephrolithiasis may be suitable candidates for this trial. As an unphased trial, it provides patients the chance to contribute to innovative research that could enhance future kidney stone treatments.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these ureteroscope devices are safe for kidney stone treatment?

Previous studies have shown that both the FANS and CVAC systems are safe for treating kidney stones.

Research indicates that FANS is well-tolerated, showing similar safety results regardless of whether the stones are infected. Patients using FANS experienced less bleeding and had shorter hospital stays compared to some other treatments.

Studies have also shown that the CVAC system is safe and effective. It successfully clears stones and leaves few leftover fragments. Real-world studies confirm its safety in various settings.

Both systems have been tested and found to be similarly safe, making them reliable options for kidney stone treatment.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the FANS and CVAC techniques for kidney stones because these methods offer potentially more efficient and less invasive options compared to traditional approaches like shock wave lithotripsy or standard ureteroscopy. The Flexible and Navigable Suction Ureteroscopy (FANS) allows for precise navigation and suction of stone fragments, potentially reducing the risk of residual stones and complications. Meanwhile, the CVAC suction ureteroscopy arm focuses on effectively removing stone fragments through enhanced suction capabilities, which could mean quicker recovery times and improved patient comfort. Both techniques aim to improve the overall success rate of kidney stone removal and provide a smoother experience for patients.

What evidence suggests that this trial's devices could be effective for kidney stones?

This trial will compare the effectiveness of CVAC and FANS for kidney stone removal. Research has shown that both CVAC and FANS effectively remove kidney stones. Participants in the CVAC arm may experience quick stone clearance; one study found it took about 47 seconds, leaving very little behind. Meanwhile, participants in the FANS arm may benefit from a 99% success rate in achieving a stone-free state, while maintaining low pressure inside the kidney to prevent damage during removal. Both devices are considered safe and effective for treating kidney stones.14567

Who Is on the Research Team?

ML

Matthew Lee, MD

Principal Investigator

Ohio State University

BK

Bodo Knudsen, MD

Principal Investigator

Ohio State University

MS

Michael Sourial, MD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for people diagnosed with kidney stones (nephrolithiasis) where the total size of their stones is between 8 and 20 mm. Participants must meet these criteria to join.

Inclusion Criteria

I have been diagnosed with kidney stones.
* Total linear stone diameter 8-20 mm in size

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ureteroscopy using either FANS or CVAC suction ureteroscope for kidney stone removal

1 day
1 visit (in-person)

Follow-up

Participants are monitored for stone free rate using CT evidence

up to 6 weeks
1-2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • CVAC
  • FANS

Trial Overview

The study compares two new suction ureteroscope devices, FANS (Flexible and Navigable Suction) and CVAC, to see which works better at removing medium to large kidney stones during ureteroscopy procedures.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: FANSActive Control1 Intervention
Group II: CVACActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials
891
Recruited
2,659,000+

Citations

First in-vivo multicenter experience with the novel CVAC 2.0 ...

A 2021 metanalysis inclusive of 9 studies, reported pooled stone free rates of 88.3% [95% CI: 78.3–98.3%] with conventional ureteroscopy, ...

CVAC2 shows safety, efficacy for stone clearance in real- ...

Overall, CVAC was shown to have significantly superior aspiration rates vs DISS across all stone size groups assessed (all, P < .001).

In Vitro Comparison of the Second-generation CVAC ...

3B). In group 1, CVAC cleared stones in 47.4 ± 6.5 seconds, significantly faster than both Pusen 3.6 Fr (85.4 ± 16.0 seconds) and Pusen 5.1 Fr ...

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.

MP29-04 PROSPECTIVE COMPARISON OF FLEXIBLE ...

In this prospective comparison of FANS and in-scope aspiration technologies, >95% stone clearance was seen in both groups despite large initial stone burdens.

NCT07155005 | Stone Clearance With Aspiration vs Other ...

The goal of this clinical trial is to evaluate the effectiveness and safety of Steerable Ureteroscopic Renal Evacuation (SURE) with the CVAC System versus other ...

Prospective, Real-World Evaluation of CVAC 2.0 In-Scope ...

In individuals with >1.5 cm preoperative stone burden, relative stone clearance was greater with CVAC 2.0 (98.9% vs 95.1%; p = 0.026). Pearson ...