Urinary StonesAEROLITHNCT04563039
Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH)
A study testing Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer and Standard Ureteroscopic Laser Lithotripsy in people with Urinary Stones, run by Avvio Medical at 23 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Urinary Stones
- What is being tested?
- Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer and Standard Ureteroscopic Laser Lithotripsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 23 sitesUnited States
- Study dates
- 21 May 2021to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 31Show fewer
- Urine pH is < 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.)
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004
Chesapeake Urology Research Associates
Baltimore, Maryland, 21204
University of Alabama
Birmingham, Alabama, 35294
Brigham and Womens Hospital
Boston, Massachusetts, 02115
Northwestern University
Chicago, Illinois, 60611
University of Florida
Gainesville, Florida, 32610
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Baylor College of Medicine
Houston, Texas, 77030
University of California
Irvine, California, 92697
University of Kansas Medical Center
Kansas City, Kansas, 66160
Arkansas Urology Research Center
Little Rock, Arkansas, 72211
University of Miami Health
Miami, Florida, 33136
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Mount Sinai West
New York, New York, 10019
Oregon Health and Sciences University
Portland, Oregon, 97239
Urology San Antonio
San Antonio, Texas, 78229
University of California
San Diego, California, 92037
University of California
San Francisco, California, 94143
Ocshner LSU Health Shreveport - Regional Urology
Shreveport, Louisiana, 71106
SUNY Upstate Medical University
Syracuse, New York, 13210
Michigan Institute of Urology
Troy, Michigan, 48084
Arizona Urology Specialists (Previously Arizona Institute of Urology, PLLC)
Tucson, Arizona, 85704
Wichita Urology Group
Wichita, Kansas, 67226
About this study
Official title: Evaluation of Applaud Medical's Acoustic Enhancer With Laser Lithotripsy System in the Treatment of Urinary Stones
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.
Read the 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.
- Conditions
- Urinary Stones
- Being tested
- Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer, Standard Ureteroscopic Laser Lithotripsy
- Keywords
- Fragmentation of calcium-based urinary stones, Fragmentation of urinary stones
- Medical subject headings
- Urinary Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic EnhancerDevice
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.
Standard Ureteroscopic Laser LithotripsyDevice
Standard of care Ureteroscopic Laser Lithotripsy
| Study group | Role | What they receive |
|---|---|---|
| Ureteroscopic Laser Lithotripsy with Acoustic Enhancer | Experimental | Ureteroscopic Laser Lithotripsy with Acoustic Enhancer Receives: Device: Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer |
| Standard Ureteroscopic Laser Lithotripsy | Active comparator | Standard Ureteroscopic Laser Lithotripsy Receives: Device: Standard Ureteroscopic Laser Lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Absence of or Have Residual Fragments Measuring Less </= to 2 mm
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
Measured: At 30 days post index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start21 May 2021
- Primary completion11 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary StonesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avvio Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tessa Yamut, Study director, Avvio Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563039
- Sponsor's protocol ID
- CIP-0001
- Acronym
- AEROLITH
- Status last verified
- Apr 2025
- First submitted
- 15 Sep 2020
- Last updated
- 24 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Mayer WA, Chi T, Wiener S, Cantrill CH, Davalos JG, Shah HN, Stoller ML. Acoustic Enhancer Microbubble Cavitation: A Randomized Clinical Trial Evaluating the Safety and Efficacy of a Novel Treatment for Urolithiasis. J Urol. 2025 Aug;214(2):167-176. doi: 10.1097/JU.0000000000004581. Epub 2025 Apr 26.
PubMed 40286438
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Applaud Medical's Acoustic Enhancer With Laser Lithotripsy System in the Treatment of Urinary Stones
- ClinicalTrials.gov ID
- NCT04563039
- Acronym / sponsor ID
- AEROLITH / CIP-0001
- Conditions
- Urinary Stones
- Keywords
- Fragmentation of calcium-based urinary stones, Fragmentation of urinary stones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Avvio MedicalIndustry (pharma, biotech, devices)
- Study start
- 21 May 2021 (actual)
- Primary completion
- 11 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 24 Sep 2020 (actual)
- Results
- Posted 24 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ureteroscopic Laser Lithotripsy with Acoustic Enhancer | Experimental | Device: Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic EnhancerUreteroscopic Laser Lithotripsy with Acoustic Enhancer |
| Standard Ureteroscopic Laser Lithotripsy | Active comparator | Device: Standard Ureteroscopic Laser LithotripsyStandard Ureteroscopic Laser Lithotripsy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (31 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic EnhancerApplaud'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. | Device | Ureteroscopic Laser Lithotripsy with Acoustic Enhancer |
| Standard Ureteroscopic Laser LithotripsyStandard of care Ureteroscopic Laser Lithotripsy | Device | Standard Ureteroscopic Laser Lithotripsy |
Primary outcome
Number of Participants With 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40286438Mayer WA, Chi T, Wiener S, Cantrill CH, Davalos JG, Shah HN, Stoller ML. Acoustic Enhancer Microbubble Cavitation: A Randomized Clinical Trial Evaluating the Safety and Efficacy of a Novel Treatment for Urolithiasis. J Urol. 2025 Aug;214(2):167-176. doi: 10.1097/JU.0000000000004581. Epub 2025 Apr 26.
- Individual participant dataSharing planned: No
Related trials for Urinary Stones
Not yet recruitingPhase 4
A Study on the Efficacy and Safety of Ningmitai Capsules in Treating Patients With Upper Urinary Tract Stones After Extracorporeal Shock Wave Lithotripsy
Calculus of Upper Urinary Tract
Enrolling by invitationObservational study
Renal Structural and Functional Alterations Following Repeated Ureteroscopic Procedures: An Exploratory Multimodal Imaging Study
Urolithiasis, Intrarenal Pressure
RecruitingObservational study
Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
Urolithiasis, Stones, Kidney
Not yet recruiting
Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
Kidney Stones, Urolithiasis, Hypocitraturia, Pain, Postoperative
Not yet recruiting
Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
Kidney Stones
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tessa Yamut study director
Avvio Medical
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer and Standard Ureteroscopic Laser Lithotripsy in people with Urinary Stones, run by Avvio Medical at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Absence of or Have Residual Fragments Measuring Less </= to 2 mm (time frame: At 30 days post index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04563039, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.