Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
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
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Ureteroscopic Laser Lithotripsy with Acoustic Enhancer
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
Standard Ureteroscopic Laser Lithotripsy
  • Device: Standard Ureteroscopic Laser Lithotripsy
    Standard of care Ureteroscopic Laser Lithotripsy

Recruiting Locations

University of Alabama
Birmingham, Alabama 35294
Contact:
Annalia Causey
amefford@uabmc.edu

More Details

Status
Recruiting
Sponsor
Applaud Medical, Inc.

Study Contact

Tessa Yamut
(408) 768-5125
tessa.yamut@applaudmedical.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.