Laser Lithotripsy for Kidney Stones
(AEROLITH Trial)

Recruiting in Palo Alto (17 mi)

+28 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Avvio Medical

No Placebo Group

Trial Summary

What is the purpose of this trial?A pivotal study to evaluate the safety and effectiveness of Applaud Acoustic Enhancer when used in conjunction with conventional ureteroscopic laser lithotripsy (URS-LL) in the treatment of subjects with urinary stones.

Eligibility Criteria

Adults aged 18-75 with kidney stones visible on a CT scan, who don't have an infection or certain medical conditions like cystinuria, recent surgeries, or involvement in other trials. Participants can have stents and bilateral stones but only one side will be treated.

Inclusion Criteria

Male or female aged ≥ 18 years to ≤ 75 years

Urinary stone(s) should be apparent on a CT scan within 60 days prior to study enrollment. Stone assessment will be conducted using CT imaging following CLIN-0025: AEROLITH IDE Study Screening Guide.

Patients may enter the study with a stent in place.

+4 more

Exclusion Criteria

Diagnosis of radiolucent stones (on the side to be treated) on KUB or Scout CT Imaging

Patients who have had prior URS-LL within 3 months on the side to be treated at the time of consent.

You have a history of a condition called cystinuria.

+27 more

Participant Groups

The study is testing the Applaud Acoustic Enhancer's safety and effectiveness alongside standard laser treatment for breaking down kidney stones. It compares outcomes of those using the enhancer with those receiving conventional treatment.

2Treatment groups

Experimental Treatment

Active Control

Group I: Ureteroscopic Laser Lithotripsy with Acoustic EnhancerExperimental Treatment1 Intervention

Ureteroscopic Laser Lithotripsy with Acoustic Enhancer

Group II: Standard Ureteroscopic Laser LithotripsyActive Control1 Intervention

Standard Ureteroscopic Laser Lithotripsy