Enhanced Lithotripsy System for Kidney Stones

(ELS Trial)

Recruiting at 3 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

Trial Summary

What is the purpose of this 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 small fragments that can pass during or after the procedure with less or no discomfort. Eligible patients are male or females, age 21 or older, with a single urinary stone in the ureter. Participants will undergo the ELS procedure and then be evaluated 30 days later for the presence or absence of urinary stone fragments on a CT scan. Other outcome measures will be changes in pain, quality of life, and return to normal daily activities/work.

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.

Is the Enhanced Lithotripsy System safe for treating kidney stones?

Research on similar systems, like the Siemens Lithostar Multiline and Dornier Lithotripter, shows they are generally safe for treating kidney stones, with many patients not needing pain medication and no long-term harm reported, even in children. ^{1 2 3 4 5}

How does the Enhanced Lithotripsy System (ELS) treatment for kidney stones differ from other treatments?

The Enhanced Lithotripsy System (ELS) is likely a novel approach to treating kidney stones, potentially offering improvements over the standard extracorporeal shock wave lithotripsy (ESWL), which is a noninvasive method that uses shock waves to break down stones. While ESWL is widely used, ELS may provide enhanced effectiveness or safety, although specific details about its unique features are not provided in the available research. ^{6 7 8 9 10}

Eligibility Criteria

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 in my ureter that is between 5 and 10 mm.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

First clinical experience and in situ treatment of ureteric stones using Lithostar Multiline lithotripter. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

The effectiveness and safety of extracorporeal shock wave lithotripsy for the management of kidney stones: A protocol of systematic review and meta-analysis. [2023]

3. Italy pubmed.ncbi.nlm.nih.gov

Laser lithotripsy in the treatment of renal stones in children. A single-center experience. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Are there long-term effects of extracorporeal shockwave lithotripsy in paediatric patients? [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Dornier Lithotripter S 220 F EMSE: the first report of over 1000 treatments. [2022]

6. Australia pubmed.ncbi.nlm.nih.gov

Lithotripsy for kidney stones. [2005]

7. Spain pubmed.ncbi.nlm.nih.gov

Analysis of the safety profile of treatment with a large number of shock waves per session in extracorporeal lithotripsy. [2017]

8. Germany pubmed.ncbi.nlm.nih.gov

[Current status of extracorporeal shockwave lithotripsy]. [2018]

9. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Extracorporeal shockwave nephro-uretero-lithotripsy]. [2007]

10. Czech Republic pubmed.ncbi.nlm.nih.gov

[Problems with indications for extracorporeal lithotripsy in urolithiasis]. [2006]