N/A
N=196
Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH)
Urinary Stones
Bottom Line
View on ClinicalTrials.gov: NCT04563039 ↗Enrolled (actual)
196
Serious AEs
4.6%
Results posted
Apr 2025
Primary outcome: Primary: Number of Participants With Absence of or Have Residual Fragments Measuring Less </= to 2 mm — 41; 42 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer (Device); Standard Ureteroscopic Laser Lithotripsy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Avvio Medical
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Absence of or Have Residual Fragments Measuring Less </= to 2 mm |
41; 42 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male or female aged ≥ 18 years to ≤ 75 years
- Provides written informed consent
- 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.
- 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.
- 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
Exclusion Criteria
- 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.
- 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 is 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.)
Data sourced from ClinicalTrials.gov (NCT04563039). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.