Pd47-11 Prospective Multicenter Study of an Enhanced Lithotripsy System to Treat Obstructive Ureteral Stones

You have accessJournal of UrologyStone Disease: Surgical Therapy (Including ESWL) IV (PD47)1 May 2024PD47-11 PROSPECTIVE MULTICENTER STUDY OF AN ENHANCED LITHOTRIPSY SYSTEM TO TREAT OBSTRUCTIVE URETERAL STONES Scott V. Wiener, Peter Chin, Niall Davis, Simon Bariol, Marshall Stoller, and Damien M. Bolton Scott V. WienerScott V. Wiener , Peter ChinPeter Chin , Niall DavisNiall Davis , Simon BariolSimon Bariol , Marshall StollerMarshall Stoller , and Damien M. BoltonDamien M. Bolton View All Author Informationhttps://doi.org/10.1097/01.JU.0001008652.62443.0a.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Urinary stone disease (USD) can be associated with significant morbidity (including pain, urosepsis and opioid addiction) while awaiting stone passage or surgical intervention. Current therapies are performed in the OR, resulting in scheduling delays, especially in the post-COVID era; a more readily available option is needed. The Enhanced Lithotripsy System (ELS) is designed to provide an alternative treatment method for USD, by providing a handheld acoustic source and inducing a shockwave multiplication effect. During the procedure, low-intensity pulses of acoustic energy from the ELS are multiplied by cavitation of Acoustic Enhancer microbubbles causing stone erosion and fragmentation. The safety and efficacy of the ELS for ureteral calculi was studied. METHODS: A prospective, multi-center, single arm, nonrandomized study design was used with enrollment of subjects with urinary stones measuring ≥3mm and ≤10mm confirmed by CT scan. Endpoints included the percent of subjects without residual fragments >3mm on CT scan (30 days following up to two ELS treatments) and device/procedure-related serious adverse effects (SAEs). We report data from subjects who received a single ELS treatment. RESULTS: Twenty-five subjects underwent a single ELS treatment and had follow-up CT imaging, with 18/25 (72%) confirmed to have no fragments >3mm on post-procedure CT imaging. Twenty-seven subjects underwent a single ELS treatment and had definitive imaging (CT, KUB, US, Ureteroscopy) to confirm the absence of stones >3mm through 30-days, with 21/27 (78%) confirmed to have no fragments >3mm on post-procedure imaging. Five patients reported a total of seven SAEs, with one determined to be possibly device and procedure related, one procedure related and possibly device related, and five determined to be unrelated to the device or the procedure. CONCLUSIONS: ELS demonstrates preliminary safety and efficacy for the treatment USD. The single treatment stone free rate observed with the ELS exceeded that previously reported for shockwave lithotripsy. These results provide the foundation for further clinical assessment of ELS for the treatment of USD. Source of Funding: This study was funded by Applaud Medical © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e985 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Scott V. Wiener More articles by this author Peter Chin More articles by this author Niall Davis More articles by this author Simon Bariol More articles by this author Marshall Stoller More articles by this author Damien M. Bolton More articles by this author Expand All Advertisement PDF downloadLoading ...