Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH)

NCT04563039 | Completed Results FDA Device

• 1 other identifier: CIP-0001
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 23

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.

Conditions

Urinary Stones

Keywords

Fragmentation of calcium-based urinary stones; Fragmentation of urinary stones

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Ureteroscopic Laser Lithotripsy with Acoustic Enhancer

EXPERIMENTAL

Ureteroscopic Laser Lithotripsy with Acoustic Enhancer

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

Standard Ureteroscopic Laser Lithotripsy

ACTIVE COMPARATOR

Standard Ureteroscopic Laser Lithotripsy

Device: Standard Ureteroscopic Laser Lithotripsy

Interventions

Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer 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.

Ureteroscopic Laser Lithotripsy with Acoustic Enhancer

Standard Ureteroscopic Laser Lithotripsy DEVICE

Standard of care Ureteroscopic Laser Lithotripsy

Standard Ureteroscopic Laser Lithotripsy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Avvio Medical: lead

Study Sites (23)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

Arizona Urology Specialists (Previously Arizona Institute of Urology, PLLC)

Tucson, Arizona, 85704, United States

Location

Arkansas Urology Research Center

Little Rock, Arkansas, 72211, United States

Location

University of California

Irvine, California, 92697, United States

Location

University of California

San Diego, California, 92037, United States

Location

University of California

San Francisco, California, 94143, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

University of Miami Health

Miami, Florida, 33136, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Wichita Urology Group

Wichita, Kansas, 67226, United States

Location

Ocshner LSU Health Shreveport - Regional Urology

Shreveport, Louisiana, 71106, United States

Location

Chesapeake Urology Research Associates

Baltimore, Maryland, 21204, United States

Location

Brigham and Womens Hospital

Boston, Massachusetts, 02115, United States

Location

Michigan Institute of Urology

Troy, Michigan, 48084, United States

Location

Mount Sinai West

New York, New York, 10019, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Oregon Health and Sciences University

Portland, Oregon, 97239, United States

Location

MidLantic Urology

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Urology San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Urinary Calculi

Condition Hierarchy (Ancestors)

Urolithiasis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: VP of RA / QA / CA
• Organization: Avvio Medical, Inc.

clinicalaffairs@avviomed.com

4158872037

Study Officials

• Tessa Yamut

  Avvio Medical

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is a double blinded study in which study subjects will not be informed of their treatment allocation through the index procedure. In assessing stone fragmentation using a CT image as defined in the primary endpoint, an independent radiologist will conduct the assessment and will be blinded to the treatment allocation of each subject's CT image.

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 24, 2020
• Study Start: May 21, 2021
• Primary Completion: July 11, 2023
• Study Completion: July 30, 2023
• Last Updated: April 24, 2025
• Results First Posted: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (23)