Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH)

NCT ID: NCT04563039

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-21
• Study Completion Date: 2023-07-30

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.

Conditions

Urinary Stones

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ureteroscopic Laser Lithotripsy with Acoustic Enhancer

Ureteroscopic Laser Lithotripsy with Acoustic Enhancer

Group Type: EXPERIMENTAL

Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer

Intervention Type: DEVICE

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.

Standard Ureteroscopic Laser Lithotripsy

Standard Ureteroscopic Laser Lithotripsy

Group Type: ACTIVE_COMPARATOR

Standard Ureteroscopic Laser Lithotripsy

Intervention Type: DEVICE

Standard of care Ureteroscopic Laser Lithotripsy

Interventions

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.

Intervention Type: DEVICE

Standard Ureteroscopic Laser Lithotripsy

Standard of care Ureteroscopic Laser Lithotripsy

Intervention Type: DEVICE

Eligibility Criteria

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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Avvio Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tessa Yamut

Role: STUDY_DIRECTOR

Avvio Medical

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CIP-0001

Identifier Type: -

Identifier Source: org_study_id