Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH) Clinical Study

  • STATUS
    Recruiting
  • End date
    Feb 10, 2022
  • participants needed
    196
  • sponsor
    Applaud Medical, Inc.
Updated on 10 June 2021

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.

Description

The AEROLITH Clinical Study will evaluate the safety and effectiveness of Applaud Acoustic Enhancer when used in conjunction with conventional ureteroscopic laser lithortipsy (URS-LL) in the treatment of subjects with urinary stones. The clinical study is a prospective, multicenter, two-arm, randomized, double blinded study. A total of 196 subjects will be enrolled in this study at up to 15 investigational sites located in the U.S.

Details
Condition Urolithiasis, Urinary calculus
Treatment Acoustic Enhancer with Ureteroscopy Laser Lithotripsy (URS-LL), Standard Ureteroscopic Laser Lithotripsy
Clinical Study IdentifierNCT04563039
SponsorApplaud Medical, Inc.
Last Modified on10 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female aged 18 years to 75 years
Provides written informed consent
Patients with at least one urinary stone and up to 3 stones located proximally to the iliac vessels on one side may be enrolled. 3a. Urinary stone(s) should be apparent on a CT scan with 30 days prior to the study enrollment. 3b. Patients with at least 1 urinary stone measuring at least 6mm but not more than 20mm in diameter. For patients with multiple stones, up to 3 stones may be treated on the treated side, with a cumulative stone diameter not exceeding 20mm. All 1-3 stones are to be treated. Stone measurement will be conducted using CT imaging
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 with urine culture within 2 weeks of the procedure

Exclusion Criteria

Patients with >3 stones on the side to be treated
Patients with 3 stones with a cumulative diameter >20mm on the side to be treated
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 below 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
Congenitally ectopic pelvic kidneys
Full staghorn calculi >2cm
Patients with elevated serum creatinine > 1.5mg/dl
Patients with a solitary kidney
Malrotated kidney on the side with urinary stone
Duplicated collecting system or duplicated ureters
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
Patients who are actively taking antiplatelet and anti-coagulation except low dose aspirin
Prostate biopsy within the last 3 months
History of radiation therapy of abdomen and pelvis
History of urinary tract reconstruction
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.)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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