Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH) (AEROLITH)

Evaluation of Applaud Medical's Acoustic Enhancer With Laser Lithotripsy System in the Treatment of Urinary Stones

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.

Study Overview

• Status: Completed
• Conditions: Urinary Stones
• Intervention / Treatment: Device: Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer; Device: Standard Ureteroscopic Laser Lithotripsy

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.

• Study Type: Interventional
• Enrollment (Actual): 196
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama
  • Arizona
    • Tucson, Arizona, United States, 85704
      • Arizona Urology Specialists (Previously Arizona Institute of Urology, PLLC)
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Urology Research Center
  • California
    • Irvine, California, United States, 92697
      • University of California
    • San Diego, California, United States, 92037
      • University of California
    • San Francisco, California, United States, 94143
      • University of California
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida
    • Miami, Florida, United States, 33136
      • University of Miami Health
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
    • Wichita, Kansas, United States, 67226
      • Wichita Urology Group
  • Louisiana
    • Shreveport, Louisiana, United States, 71106
      • Ocshner LSU Health Shreveport - Regional Urology
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Chesapeake Urology Research Associates
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Womens Hospital
  • Michigan
    • Troy, Michigan, United States, 48084
      • Michigan Institute of Urology
  • New York
    • New York, New York, United States, 10019
      • Mount Sinai West
    • Syracuse, New York, United States, 13210
      • Suny Upstate Medical University
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Sciences University
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • MidLantic Urology
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Urologic Research Center
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • San Antonio, Texas, United States, 78229
      • Urology San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male or female aged ≥ 18 years to ≤ 75 years
2. Provides written informed consent
3. 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.
4. 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.
5. Patients with bilateral stones are allowed but only one side may be treated. Only the treated side will be evaluated for safety and effectiveness
6. Patients may enter the study with a stent in place.
7. Patients presenting with absence of a Urinary Tract Infection as confirmed using urinalysis

Exclusion Criteria:

1. 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.
2. Patients with ureteral stones located distal to the iliac vessels on the side to be treated
3. Diagnosis of radiolucent stones (on the side to be treated) on KUB or Scout CT Imaging
4. 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)
5. Patients who have had prior URS-LL within 3 months on the side to be treated at the time of consent.
6. History of cystinuria
7. Urine pH is < 5.5.
8. Patients with known history of recurrent uric acid stones
9. Untreated urinary tract infection (UTI)
10. History of drug-resistant chronic UTI
11. If female, pregnant as confirmed using urine test to be conducted on the day of the procedure.
12. Patient has an American Society of Anesthesiologists (ASA) physical classification level of 4 or greater.
13. 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
14. Stones suspected in calyceal diverticula
15. Horseshoe kidney
16. Congenitally ectopic pelvic kidneys
17. Full staghorn calculi >2cm
18. Patients with elevated serum creatinine > 1.5mg/dl
19. Patients with a solitary kidney
20. Malrotated kidney on the side with urinary stone
21. Duplicated collecting system or duplicated ureters
22. 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
23. Patients who are actively taking antiplatelet and anti-coagulation except low dose aspirin
24. Prostate biopsy within the last 3 months
25. History of radiation therapy of abdomen and pelvis
26. History of urinary tract reconstruction

27. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ureteroscopic Laser Lithotripsy with Acoustic Enhancer	Device: Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer; Applaud's Acoustic Enhancer is provided in a lyophilized form. After reconstitution, it is a liquid, containing micron-scale particles that are made of a perfluoroalkane gas core with a lipid shell. The device is intended to be used with cleared/approved pulsed laser systems in fragmenting urinary stones (calculi) in the upper (superior) pole, lower (inferior) pole, and interpolar region of the kidney, pelvis of the kidney, and proximal ureter.
Active Comparator: Standard Ureteroscopic Laser Lithotripsy	Device: Standard Ureteroscopic Laser Lithotripsy; Standard of care Ureteroscopic Laser Lithotripsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Absence of or Have Residual Fragments Measuring Less </= to 2 mm	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	At 30 days post index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Total Radiant Energy Used in the Treatment	Total radiant energy is defined as mean value of laser energy that will be measured for each study arm	At 30 days post index procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Measurement of Lasering Time During Treatment	Total lasering time will be evaluated for each study arm	At 30 days post index procedure
Efficacy: Proportion of study subjects undergoing additional interventional stone treatment	Proportion of subjects receiving additional intervention following treatment with either the Acoustic Enhancer with URS-LL or standard URS-LL	Through 90 days post index procedure
Safety: Proportion of Adverse Events	Device, procedure, device and procedure related adverse events as well as severity of each adverse event will be measured for each subject	Through 90 days post index procedure

Collaborators and Investigators

• Sponsor: Avvio Medical
• Investigators: Study Director: Tessa Yamut, Avvio Medical

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2021
• Primary Completion (Actual): July 11, 2023
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: September 18, 2020
• First Posted (Actual): September 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Fragmentation of calcium-based urinary stones; Fragmentation of urinary stones
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Calculi; Urolithiasis
• Other Study ID Numbers: CIP-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No