Clinical trial NCT04563039: Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH)
Official title: Evaluation of Applaud Medical's Acoustic Enhancer With Laser Lithotripsy System in the Treatment of Urinary Stones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Stones
Keywords: Fragmentation of calcium-based urinary stones
Fragmentation of urinary stones
Lead sponsor: Avvio Medical
Sponsor class: INDUSTRY
First posted: 2020-09-24
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.)

Primary outcomes:
measure: Number of Participants With Absence of or Have Residual Fragments Measuring Less </= to 2 mm
timeFrame: At 30 days post index procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Tucson
country: United States
facility: Arizona Urology Specialists (Previously Arizona Institute of Urology, PLLC)
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Urology Research Center
state: Arkansas
city: Irvine
country: United States
facility: University of California
state: California
city: San Diego
country: United States
facility: University of California
state: California
city: San Francisco
country: United States
facility: University of California
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: University of Miami Health
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Wichita
country: United States
facility: Wichita Urology Group
state: Kansas
city: Shreveport
country: United States
facility: Ocshner LSU Health Shreveport - Regional Urology
state: Louisiana
city: Baltimore
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Boston
country: United States
facility: Brigham and Womens Hospital
state: Massachusetts
city: Troy
country: United States
facility: Michigan Institute of Urology
state: Michigan
city: New York
country: United States
facility: Mount Sinai West
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Portland
country: United States
facility: Oregon Health and Sciences University
state: Oregon
city: Bala-Cynwyd
country: United States
facility: MidLantic Urology
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio
state: Texas
Study officials:
affiliation: Avvio Medical
name: Tessa Yamut
role: STUDY_DIRECTOR
References: