Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH)

Completed · Not applicable

Conditions studied: Urinary Stones

In brief

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.

Key facts

Study ID

NCT04563039

Run by

Avvio Medical

People needed

196

Starts

2021-05-21

Expected to finish

2023-07-30

Last updated by the study team

2025-04-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female aged ≥ 18 years to ≤ 75 years
• Provides written informed consent
• Patients with at least one urinary stone measuring 6mm or greater (but no more than a cumulative diameter of 20mm) located proximally to the iliac vessels on one side may be treated.
• 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 with bilateral stones are allowed but only one side may be treated. Only the treated side will be evaluated for safety and effectiveness
• Patients may enter the study with a stent in place.
• Patients presenting with absence of a Urinary Tract Infection as confirmed using urinalysis

You may not qualify if…

• Patients with stones exceeding a cumulative diameter of 20mm on the side to be treated. Note: Punctate stones measuring ≤ 2mm do not count in the cumulative diameter limit.
• Patients with ureteral stones located distal to the iliac vessels on the side to be treated
• Diagnosis of radiolucent stones (on the side to be treated) on KUB or Scout CT Imaging
• For patients who have a ureteral stent in place, patient is excluded if stent is calcified or encrusted as verified using standard of care imaging (e.g. KUB X-ray)
• Patients who have had prior URS-LL within 3 months on the side to be treated at the time of consent.
• History of cystinuria
• Urine pH is < 5.5.
• Patients with known history of recurrent uric acid stones
• Untreated urinary tract infection (UTI)
• History of drug-resistant chronic UTI
• If female, pregnant as confirmed using urine test to be conducted on the day of the procedure.
• Patient has an American Society of Anesthesiologists (ASA) physical classification level of 4 or greater.
• Known sensitivity to possible medications used before, during, or after the URS Laser Lithotripsy procedure, including but not limited to the following: sedative agents, general anesthetics, topical anesthetics, and opioid analgesics
• Stones suspected in calyceal diverticula
• Horseshoe kidney
• Congenitally ectopic pelvic kidneys
• Full staghorn calculi >2cm
• Patients with elevated serum creatinine > 1.5mg/dl
• Patients with a solitary kidney
• Malrotated kidney on the side with urinary stone
• Duplicated collecting system or duplicated ureters
• Patients who are currently involved in any investigational drug or device trial or have been enrolled in such trials within 30 days of index procedure
• Patients who are actively taking antiplatelet and anti-coagulation except low dose aspirin
• Prostate biopsy within the last 3 months
• History of radiation therapy of abdomen and pelvis

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Arizona Urology Specialists (Previously Arizona Institute of Urology, PLLC) — Tucson, Arizona, United States
• Arkansas Urology Research Center — Little Rock, Arkansas, United States
• University of California — Irvine, California, United States
• University of California — San Diego, California, United States
• University of California — San Francisco, California, United States
• University of Florida — Gainesville, Florida, United States
• University of Miami Health — Miami, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Wichita Urology Group — Wichita, Kansas, United States
• Ocshner LSU Health Shreveport - Regional Urology — Shreveport, Louisiana, United States
• Chesapeake Urology Research Associates — Baltimore, Maryland, United States
• Brigham and Womens Hospital — Boston, Massachusetts, United States
• Michigan Institute of Urology — Troy, Michigan, United States
• Mount Sinai West — New York, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• Oregon Health and Sciences University — Portland, Oregon, United States
• MidLantic Urology — Bala-Cynwyd, Pennsylvania, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
• Baylor College of Medicine — Houston, Texas, United States
• Urology San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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