Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH)

Not Applicable

Completed

Conditions: Urinary Stones

Interventions: Device: Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer
Device: Standard Ureteroscopic Laser Lithotripsy

Registration Number: NCT04563039

Lead Sponsor: Avvio Medical

Brief Summary: 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.

Detailed Description: The AEROLITH Clinical Study will 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. The clinical study is a prospective, multi-center, two-arm, randomized, double blinded study.

A total of 196 subjects will be enrolled in this study at up to 27 investigational sites located in the U.S.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 196

Inclusion Criteria

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

Exclusion Criteria

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
History of urinary tract reconstruction
Other factors that the investigator feels would interfere with the participation and completion of the study such as:
- Inability to provide voluntary consent
- Inability to understand the clinical investigation or cooperate with investigational procedures
- Planned relocation or unable to return for required follow-up visits
- Vulnerable individuals (mentally disabled, physically disabled, prisoner, etc.)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ureteroscopic Laser Lithotripsy with Acoustic Enhancer	Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer	Ureteroscopic Laser Lithotripsy with Acoustic Enhancer
Standard Ureteroscopic Laser Lithotripsy	Standard Ureteroscopic Laser Lithotripsy	Standard Ureteroscopic Laser Lithotripsy

Primary Outcome Measures

Name	Time	Method
Number of Participants With Absence of or Have Residual Fragments Measuring Less </= to 2 mm	At 30 days post index procedure	Study subjects who present with a complete absence of stones, or have residual fragments measuring less than or equal to 2 mm on the treatment side, as assessed by CT imaging

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (21): Arizona Urology Specialists (Previously Arizona Institute of Urology, PLLC)
🇺🇸
Tucson, Arizona, United States
Wichita Urology Group
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Wichita, Kansas, United States
Chesapeake Urology Research Associates
🇺🇸
Baltimore, Maryland, United States
Carolina Urologic Research Center
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Myrtle Beach, South Carolina, United States
Mount Sinai West
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New York, New York, United States
Penn State Milton S. Hershey Medical Center
🇺🇸
Hershey, Pennsylvania, United States
SUNY Upstate Medical University
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Syracuse, New York, United States
Northwestern University
🇺🇸
Chicago, Illinois, United States
Brigham and Womens Hospital
🇺🇸
Boston, Massachusetts, United States
Baylor College of Medicine
🇺🇸
Houston, Texas, United States
University of Miami Health
🇺🇸
Miami, Florida, United States
Arkansas Urology Research Center
🇺🇸
Little Rock, Arkansas, United States
University of Florida
🇺🇸
Gainesville, Florida, United States
University of Alabama
🇺🇸
Birmingham, Alabama, United States
Oregon Health and Sciences University
🇺🇸
Portland, Oregon, United States
University of California
🇺🇸
San Francisco, California, United States
MidLantic Urology
🇺🇸
Bala-Cynwyd, Pennsylvania, United States
Urology San Antonio
🇺🇸
San Antonio, Texas, United States
Michigan Institute of Urology
🇺🇸
Troy, Michigan, United States
Ocshner LSU Health Shreveport - Regional Urology
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Shreveport, Louisiana, United States
University of Kansas Medical Center
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Kansas City, Kansas, United States