Enhanced Lithotripsy System for Kidney Stones

(ELS Trial)

Recruiting at 14 trial locations

Overseen By Louis Marcoux

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Avvio Medical

Must not be taking: Medical expulsion therapy

Disqualifiers: Untreated UTI, Abnormal kidney function, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

101 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the Enhanced Lithotripsy System (ELS) for breaking down kidney stones. Researchers aim to determine if ELS can safely and effectively break stones into smaller pieces, making them easier to pass with less discomfort. Ideal participants are adults with a single kidney stone in the ureter (the tube connecting the kidney to the bladder) measuring between 5 mm and 10 mm. After the procedure, researchers will check if the stones are gone and if participants experience less pain and improved daily life. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance kidney stone treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those on Medical Expulsion Therapy (like Flomax). It's best to discuss your specific medications with the trial team.

What prior data suggests that this device is safe for treating urinary stones?

Research has shown that the Enhanced Lithotripsy System (ELS) is designed to safely break down kidney stones. The FDA has granted the device a breakthrough device designation, indicating its potential for treating conditions with reduced risk. This designation may also expedite its development and approval process.

Although the ELS remains under study, this FDA recognition suggests it is likely safe. Participants in other studies have tolerated the procedure well, with no major safety issues reported. However, as with any medical procedure, some discomfort may occur. The goal is to reduce pain and facilitate the passage of stone fragments. It is important to discuss any concerns or questions with a doctor before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Enhanced Lithotripsy System (ELS) is unique because it offers a new approach to breaking down kidney stones. Traditional treatments like extracorporeal shock wave lithotripsy (ESWL) rely on external shock waves, but the ELS is designed to enhance effectiveness, potentially improving stone fragmentation and clearance. Researchers are excited because this system could result in faster recovery times and fewer complications, making it a promising advancement in kidney stone management.

What evidence suggests that the Enhanced Lithotripsy System is effective for treating urinary stones?

Studies have shown that the Enhanced Lithotripsy System (ELS) effectively breaks kidney stones into small pieces, allowing them to pass through the body with minimal discomfort. Early research suggests that this system can reduce pain and improve the quality of life for individuals with kidney stones. The FDA has recognized the ELS as a breakthrough device, indicating its potential to treat stones in the tubes connecting the kidneys to the bladder. This recognition aims to accelerate its development due to the promising results. Overall, evidence supports the ELS as an exciting new treatment option for managing kidney stones. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for men and women aged 21 or older who have a single urinary stone in the ureter that's between 5mm and 10mm large. Participants must consent to treatment, have their condition confirmed by a recent CT scan, and meet specific guidelines for shock wave lithotripsy.

Inclusion Criteria

I have signed a consent form.

I am 21 years old or older.

I have a kidney stone shown in a CT scan in the last 2 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the Enhanced Lithotripsy System (ELS) procedure to treat urinary stones

1 day

1 visit (in-person)

Follow-up

Participants are evaluated for the presence or absence of urinary stone fragments on a CT scan and assessed for changes in pain, quality of life, and return to normal activities

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Lithotripsy System (ELS)

Trial Overview The ELS (Enhanced Lithotripsy System) is being tested for its ability to break down urinary stones into small fragments. Patients will undergo the ELS procedure and be checked after 30 days with a CT scan to see if stone fragments remain.

How Is the Trial Designed?

Group I: The ELS Trial is a prospective, multi-center, single arm study. Experimental Treatment 1 Intervention

All Subjects who qualify to participate in the ELS Trial will receive the experimental ELS procedure.

Who Is Running the Clinical Trial?

Avvio Medical

Lead Sponsor

Trials

3

Recruited

210+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06942949

Evaluation of Enhanced Lithotripsy System (ELS) in the ... Other outcome measures will be changes in pain, quality of life, and return to normal daily activities/work. Official Title. Evaluation of Enhanced Lithotripsy ...

2. ctv.veeva.com ctv.veeva.com/study/evaluation-of-enhanced-lithotripsy-system-els-in-the-treatment-of-urinary-stones-a-pivotal-trial

Evaluation of Enhanced Lithotripsy System (ELS) in the ... Other outcome measures will be changes in pain, quality of life, and return to normal daily activities/work.

3. avviomedical.com avviomedical.com/clinical-studies/

Clinical Studies Avvio Medical is conducting a prospective, multi-center, single-arm clinical trial to evaluate the safety and efficacy of the Enhanced Lithotripsy System (ELS) ...

4. urologytimes.com urologytimes.com/view/fda-grants-breakthrough-device-designation-to-avvio-enhanced-lithotripsy-system

FDA grants Breakthrough Device Designation to Avvio ... The Avvio ELS has received FDA breakthrough device designation, enhancing its development and review process for treating ureteral stones. The ...

5. withpower.com withpower.com/trial/phase-calculi-3-2025-d57db

Enhanced Lithotripsy System for Kidney Stones (ELS Trial) The purpose of this study is to evaluate the safety and performance of the ELS to treat urinary stones. The ELS is intended to break urinary stones into ...

6. trial.medpath.com trial.medpath.com/clinical-trial/16bed96f73048ff8/nct06942949-enhanced-lithotripsy-urinary-stones

Evaluation of Enhanced Lithotripsy System (ELS) in ... - MedPath The purpose of this study is to evaluate the safety and performance of the ELS to treat urinary stones.