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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04563039
Recruitment Status : Recruiting
First Posted : September 24, 2020
Last Update Posted : November 14, 2022
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: Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer 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 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.

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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)
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 : December 2022
Estimated Study Completion Date : March 2023

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Efficacy: Absence of or have residual fragments measuring less </= to 2 mm [ Time Frame: At 30 days post index procedure ]
    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


Secondary Outcome Measures :
  1. Safety: Total Radiant Energy Used in the Treatment [ Time Frame: 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: At 30 days post index procedure ]
    Total lasering time will be evaluated for each study arm

  2. Efficacy: Proportion of study subjects undergoing additional interventional stone treatment [ Time Frame: 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 Adverse Events [ Time Frame: 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 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.)

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
Show Show 26 study locations
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: November 14, 2022
Last Verified: November 2022
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