Summary

Eligibility
for people ages 18-75 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UC Irvine UCSD UCSF
Dates
study started
estimated completion

Description

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.

Official Title

Evaluation of Applaud Medical's Acoustic Enhancer With Laser Lithotripsy System in the Treatment of Urinary Stones

Details

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.

Keywords

Urinary Stones Fragmentation of calcium-based urinary stones Fragmentation of urinary stones Urinary Calculi Urolithiasis Acoustic Enhancer with Ureteroscopy Laser Lithotripsy (URS-LL)

Eligibility

You can join if…

Open to people ages 18-75

  1. Male or female aged ≥ 18 years to ≤ 75 years
  2. Provides written informed consent
  3. 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.
  4. Patients with bilateral stones are allowed but only one side may be treated. Only the treated side will be evaluated for safety and effectiveness.
  5. Patients may enter the study with a stent in place.
  6. Patients presenting with absence of a Urinary Tract Infection as confirmed using urinalysis

You CAN'T join if...

  1. Patients with >3 stones on the side to be treated
  2. Patients with 3 stones with a cumulative diameter >20mm on the side to be treated
  3. Patients with ureteral stones located distal to the iliac vessels on the side to be treated
  4. Diagnosis of radiolucent stones (on the side to be treated) on KUB or Scout CT Imaging
  5. 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)
  6. Patients who have had prior URS-LL within 3 months on the side to be treated at the time of consent.
  7. History of cystinuria
  8. Urine pH below 5.5
  9. Patients with known history of recurrent uric acid stones
  10. . Untreated urinary tract infection (UTI)
  11. . History of drug-resistant chronic UTI
  12. . If female, pregnant as confirmed using urine test to be conducted on the day of the procedure.
  13. . Patient has an American Society of Anesthesiologists (ASA) physical classification level of 4 or greater.
  14. . 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

  1. . Stones suspected in calyceal diverticula
  2. . Horseshoe kidney
  3. . Congenitally ectopic pelvic kidneys
  4. . Full staghorn calculi >2cm
  5. . Patients with elevated serum creatinine > 1.5mg/dl
  6. . Patients with a solitary kidney
  7. . Malrotated kidney on the side with urinary stone
  8. . Duplicated collecting system or duplicated ureters
  9. . 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
  10. . Patients who are actively taking antiplatelet and anti-coagulation except low dose aspirin
  11. . Prostate biopsy within the last 3 months
  12. . History of radiation therapy of abdomen and pelvis
  13. . History of urinary tract reconstruction
  14. . Other factors that the investigator feels would interfere with the participation and completion of the study such as:
  15. Inability to provide voluntary consent
  16. Inability to understand the clinical investigation or cooperate with investigational procedures
  17. Planned relocation or unable to return for required follow-up visits
  18. Vulnerable individuals (mentally disabled, physically disabled, prisoner, etc.)

Locations

  • University of California accepting new patients
    Irvine California 92697 United States
  • University of California accepting new patients
    San Diego California 92037 United States
  • University of California accepting new patients
    San Francisco California 94143 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Applaud Medical, Inc.
ID
NCT04563039
Study Type
Interventional
Last Updated