An interventional study of Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer and Standard Ureteroscopic Laser Lithotripsy in Urinary Stones, sponsored by Avvio Medical. Completed at 23 sites in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-24.
Sponsored by Avvio Medical · Not applicable, Interventional, and Treatment
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.
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.
94 studies on the registry are indexed under Urinary Calculi; 20 are open to participants now.
This study's enrollment of 196 is above the median of 120 across 61 interventional studies indexed under Urinary Calculi.
Browse Urinary Calculi studies →Avvio Medical is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other factors that the investigator feels would interfere with the participation and completion of the study such as:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ureteroscopic Laser Lithotripsy with Acoustic Enhancer
Device: Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer
Standard Ureteroscopic Laser Lithotripsy
Device: Standard Ureteroscopic Laser Lithotripsy
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 of care Ureteroscopic Laser Lithotripsy
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
Time frame: At 30 days post index procedure
| Milestone | Ureteroscopic Laser Lithotripsy With Acoustic Enhancer | Standard Ureteroscopic Laser Lithotripsy |
|---|---|---|
| Started | 103 | 93 |
| Completed | 100 | 90 |
| Not completed | 3 | 3 |
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
| participants | Ureteroscopic Laser Lithotripsy With Acoustic Enhancer | Standard Ureteroscopic Laser Lithotripsy |
|---|---|---|
| Number of Participants With Absence of or Have Residual Fragments Measuring Less </= to 2 mm | 41 | 42 |
Collected over 30 days (+ 14 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ureteroscopic Laser Lithotripsy With Acoustic Enhancer | 0/103 (0%) | 4/103 (3.9%) | 36/103 (35%) |
| Standard Ureteroscopic Laser Lithotripsy | 0/93 (0%) | 5/93 (5.4%) | 43/93 (46.2%) |
| Event | Ureteroscopic Laser Lithotripsy With Acoustic Enhancer | Standard Ureteroscopic Laser Lithotripsy |
|---|---|---|
| Infection: Urinary TractRenal and urinary disorders | 4/103 | 2/93 |
| PsychologicalPsychiatric disorders | 0/103 | 1/93 |
| PainRenal and urinary disorders | 0/103 | 1/93 |
| Pulmonary / respiratoryRespiratory, thoracic and mediastinal disorders | 0/103 | 1/93 |
| Infection: Genital urinaryReproductive system and breast disorders | 1/103 | 0/93 |
| SteinstrasseRenal and urinary disorders | 1/103 | 0/93 |
| Event | Ureteroscopic Laser Lithotripsy With Acoustic Enhancer | Standard Ureteroscopic Laser Lithotripsy |
|---|---|---|
| Pain: flank pain, ipsilateralGeneral disorders | 7/103 | 6/93 |
| Pain: DysuriaRenal and urinary disorders | 3/103 | 5/93 |
| NauseaGastrointestinal disorders | 3/103 | 4/93 |
| Infection in the genitourinary systemInfections and infestations | 4/103 | 3/93 |
| Nausea and vomitingGastrointestinal disorders | 1/103 | 3/93 |
| COVID-19 relatedRespiratory, thoracic and mediastinal disorders | 0/103 | 3/93 |
| Pain: Abdominal colicGeneral disorders | 1/103 | 3/93 |
| Pain involved with stent placement / removal and possible dislodgingGeneral disorders | 2/103 | 3/93 |
| HydronephrosisRenal and urinary disorders | 3/103 | 3/93 |
| Altered bowel pattersGastrointestinal disorders | 0/103 | 2/93 |
| Age, Categorical(Participants) | Ureteroscopic Laser Lithotripsy With Acoustic Enhancer | Standard Ureteroscopic Laser Lithotripsy | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 103 | 93 | 196 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Ureteroscopic Laser Lithotripsy With Acoustic Enhancer | Standard Ureteroscopic Laser Lithotripsy | Total |
|---|---|---|---|
| Mean | 50.8 (21 to 75) | 54.7 (19 to 75) | 52.7 (19 to 75) |
| Sex: Female, Male(Participants) | Ureteroscopic Laser Lithotripsy With Acoustic Enhancer | Standard Ureteroscopic Laser Lithotripsy | Total |
|---|---|---|---|
| Female | 52 | 46 | 98 |
| Male | 51 | 47 | 98 |
| Ethnicity (NIH/OMB)(Participants) | Ureteroscopic Laser Lithotripsy With Acoustic Enhancer | Standard Ureteroscopic Laser Lithotripsy | Total |
|---|---|---|---|
| Hispanic or Latino | 18 | 14 | 32 |
| Not Hispanic or Latino | 85 | 79 | 164 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Ureteroscopic Laser Lithotripsy With Acoustic Enhancer | Standard Ureteroscopic Laser Lithotripsy | Total |
|---|---|---|---|
| United States | 103 | 93 | 196 |
| BMI(kg/m^2) | Ureteroscopic Laser Lithotripsy With Acoustic Enhancer | Standard Ureteroscopic Laser Lithotripsy | Total |
|---|---|---|---|
| Mean | 31.183 (14.2 to 64.58) | 30.785 (19.57 to 61.2) | 30.994 (14.2 to 64.58) |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2021 to primary completion in Jul 2023, 25 months.
Results were first posted in Apr 2025, 1 year 9 months after primary completion.
Of 31 interventional studies with no phase under Urinary Calculi, half reached primary completion within 74 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 79. This study's 25 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Avvio Medical