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Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH) Clinical Study (AEROLITH)

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ClinicalTrials.gov Identifier: NCT04563039
Recruitment Status : Recruiting
First Posted : September 24, 2020
Last Update Posted : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
Applaud Medical, Inc.

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.

Condition or disease Intervention/treatment Phase
Urinary Stones Device: Acoustic Enhancer with Ureteroscopy Laser Lithotripsy (URS-LL) Device: Standard Ureteroscopic Laser Lithotripsy Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 196 participants
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.
Masking: Double (Participant, Outcomes Assessor)
Masking 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
Official Title: Evaluation of Applaud Medical's Acoustic Enhancer With Laser Lithotripsy System in the Treatment of Urinary Stones
Actual Study Start Date : May 21, 2021
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : February 2022

Arm Intervention/treatment
Experimental: Acoustic Enhancer with Ureteroscopic Laser Lithotripsy
Ureteroscopic Laser Lithotripsy with Acoustic Enhancer
Device: Acoustic Enhancer with Ureteroscopy Laser Lithotripsy (URS-LL)
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




Primary Outcome Measures :
  1. Efficacy of the treatment study subjects who present with a complete absence or have residual fragments measuring less </= to 2 mm on the treatment side [ Time Frame: Efficacy of the treatment will be evaluated at 30 days post index procedure ]
    Efficacy of the treatment is defined as 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 through 30-day follow-up post index procedure.


Secondary Outcome Measures :
  1. Safety: Total Radiant Energy Used in the Treatment [ Time Frame: Total radiant energy will be evaluated at 30 days post index procedure ]
    Total radiant energy is defined as mean value of laser energy that will be measured for each study arm


Other Outcome Measures:
  1. Safety: Measurement of Lasering Time During Treatment [ Time Frame: Measurement of mean total lasering time for each arm be evaluated at 30 days post index procedure ]
    Measurement of total lasering time will be evaluated for each study arm

  2. Efficacy: Proportion of study subjects undergoing additional interventional stone treatment [ Time Frame: Outcome will be evaluated through 90 days post index procedure ]
    Proportion of subjects receiving additional intervention following treatment with either the Acoustic Enhancer with URS-LL or standard URS-LL

  3. Safety: Proportion of device, procedure, device and procedure related adverse events [ Time Frame: Safety will be evaluated through 90 days post index procedure ]
    Device, procedure, device and procedure related adverse events as well as severity of each adverse event will be measured for each subject



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 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

Exclusion Criteria:

  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
  15. Stones suspected in calyceal diverticula
  16. Horseshoe kidney
  17. Congenitally ectopic pelvic kidneys
  18. Full staghorn calculi >2cm
  19. Patients with elevated serum creatinine > 1.5mg/dl
  20. Patients with a solitary kidney
  21. Malrotated kidney on the side with urinary stone
  22. Duplicated collecting system or duplicated ureters
  23. 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
  24. Patients who are actively taking antiplatelet and anti-coagulation except low dose aspirin
  25. Prostate biopsy within the last 3 months
  26. History of radiation therapy of abdomen and pelvis
  27. History of urinary tract reconstruction
  28. 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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04563039


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

Locations
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United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35294
Contact: Kyle Wood, MD       kylewood@uabmc.edu   
United States, Arizona
Arizona Institute of Urology, PLLC Recruiting
Tucson, Arizona, United States, 85704
Contact: Jay Page, MD       jpage@aiurology.com   
United States, California
University of California Recruiting
Irvine, California, United States, 92697
Contact: Roshan Patel, MD       roshanmp@hs.uci.edu   
University of California Recruiting
San Diego, California, United States, 92037
Contact: Roger Sur, MD       rlsur@health.ucsd.edu   
University of California Recruiting
San Francisco, California, United States, 94143
Contact: Thomas Chi, MD       Tom.chi@ucsf.edu   
United States, Colorado
Advanced Urology, PLLC Not yet recruiting
Lakewood, Colorado, United States, 80228
Contact: David J. Cahn, MD       dcahn@coloradouro.com   
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Vincent Bird, MD       Vincent.bird@urology.ufl.edu   
United States, Illinois
Northwestern University Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Amy Krambeck, MD       amy.krambeck@nm.org   
United States, Maryland
Chesapeake Urology Associates Recruiting
Baltimore, Maryland, United States, 21204
Contact: Julio Davalos, MD       jdavalos@chesuro.com   
United States, Massachusetts
Brigham and Womens Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Daniel Wollin, MD       dwollin@partners.org   
United States, New York
Mount Sinai West Recruiting
New York, New York, United States, 10019
Contact: Mantu Gupta, MD       Mantu.gupta@mountsinai.org   
SUNY Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Scott Weiner, MD       WienerSc@upstate.edu   
United States, Ohio
Ohio State University Not yet recruiting
Columbus, Ohio, United States, 43212
Contact: Bodo Knudsen, MD       bodo.knudsen@osumc.edu   
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15219
Contact: Michelle Semins, MD       seminsmj@upmc.edu   
Sponsors and Collaborators
Applaud Medical, Inc.
Investigators
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Study Director: Tessa Yamut Applaud Medical, Inc.
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Responsible Party: Applaud Medical, Inc.
ClinicalTrials.gov Identifier: NCT04563039    
Other Study ID Numbers: CIP-0001
First Posted: September 24, 2020    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Applaud Medical, Inc.:
Fragmentation of calcium-based urinary stones
Fragmentation of urinary stones
Additional relevant MeSH terms:
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Urinary Calculi
Urolithiasis
Calculi
Pathological Conditions, Anatomical
Urologic Diseases