LBA01-14 BREAK WAVE ^TM LITHOTRIPSY FOR UROLITHIASIS: RESULTS OF THE FIRST-IN-HUMAN INTERNATIONAL MULTICENTER CLINICAL TRIAL

You have accessJournal of UrologyCME1 Apr 2023LBA01-14 BREAK WAVETM LITHOTRIPSY FOR UROLITHIASIS: RESULTS OF THE FIRST-IN-HUMAN INTERNATIONAL MULTICENTER CLINICAL TRIAL Ben H. Chew, Jonathan D. Harper, Roger L. Sur, Thomas Chi, Shubha De, Anne R. Buckley, Ryan F. Paterson, Connor M. Forbes, M. Kennedy Hall, Ross Kessler, Seth K. Bechis, Jason R. Woo, Ralph C. Wang, David B. Bayne, Derek Bochinski, Trevor D. Schuler, Tim Wollin, Rahim Samji, and Mathew D. Sorensen Ben H. ChewBen H. Chew More articles by this author , Jonathan D. HarperJonathan D. Harper More articles by this author , Roger L. SurRoger L. Sur More articles by this author , Thomas ChiThomas Chi More articles by this author , Shubha DeShubha De More articles by this author , Anne R. BuckleyAnne R. Buckley More articles by this author , Ryan F. PatersonRyan F. Paterson More articles by this author , Connor M. ForbesConnor M. Forbes More articles by this author , M. Kennedy HallM. Kennedy Hall More articles by this author , Ross KesslerRoss Kessler More articles by this author , Seth K. BechisSeth K. Bechis More articles by this author , Jason R. WooJason R. Woo More articles by this author , Ralph C. WangRalph C. Wang More articles by this author , David B. BayneDavid B. Bayne More articles by this author , Derek BochinskiDerek Bochinski More articles by this author , Trevor D. SchulerTrevor D. Schuler More articles by this author , Tim WollinTim Wollin More articles by this author , Rahim SamjiRahim Samji More articles by this author , and Mathew D. SorensenMathew D. Sorensen More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003360.14AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Break Wave lithotripsy is a new non-invasive technology for the treatment of urolithiasis that can be performed with little to no anesthesia, potentially allowing stone treatment in non-operative settings. This study reports safety, efficacy, and anesthesia requirements from a first-in-human, prospective, multicenter, open-label single-arm clinical trial (NCT03811171) utilizing the SonoMotion (San Mateo, CA) Break Wave device. METHODS: Forty-four (44) patients with ureteral or renal stones were treated across five North American centers (US/Canada) between 08/2019 – 02/2022. Patients were recruited and treated in the operating room, office/clinic, or emergency department (ED). Thirty minutes of Break Wave therapy was delivered under continuous ultrasonography targeting. Varying therapy dose levels up to 8MPa of acoustic pressure were administered and safety, effectiveness and anesthesia requirements were assessed to establish optimal dose settings. The efficacy objective was stone free rate or fragments≤4 mm assessed via non-contrast CT at 8-12 weeks by an independent radiologist. Patients were followed for 90 days with all adverse events (AEs) recorded. RESULTS: Target stones were in typical locations and sizes (Table 1) with 59% renal (n=26) and 41% in the distal ureter (DU) (n=18). No serious AEs, hematomas, cardiac arrythmia or sepsis occurred at any dose level. Overall, 86% of subjects received either no medication (50%) or minor analgesia (36%) (e.g., ketorolac 15-30mg). All patients completed the procedure. Stone fragmentation occurred in 88% of cases, with 70% of subjects being either completely stone free or with fragments≤4 mm on CT. The retreatment rate was 7% within 90 days with either SWL or URS. The optimal dose setting was identified and delivered to 36 of 44 patients. Of these 36 patients, 75% had fragments ≤ 4mm and 58% were completely stone free, 71% of lower pole patients (n=14) had fragments ≤ 4mm with 29% stone free, and 89% of distal ureteral stones (n=18) were completely stone free. CONCLUSIONS: Break Wave Lithotripsy appears to be a safe and effective non-invasive stone therapy requiring little to no anesthesia. It is potentially suitable for non-operative environments such as the office or ED and is being evaluated in ongoing trials. Source of Funding: Sonomotion, Inc.NIH – NIDDK (R44DK109779) © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1182 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Ben H. Chew More articles by this author Jonathan D. Harper More articles by this author Roger L. Sur More articles by this author Thomas Chi More articles by this author Shubha De More articles by this author Anne R. Buckley More articles by this author Ryan F. Paterson More articles by this author Connor M. Forbes More articles by this author M. Kennedy Hall More articles by this author Ross Kessler More articles by this author Seth K. Bechis More articles by this author Jason R. Woo More articles by this author Ralph C. Wang More articles by this author David B. Bayne More articles by this author Derek Bochinski More articles by this author Trevor D. Schuler More articles by this author Tim Wollin More articles by this author Rahim Samji More articles by this author Mathew D. Sorensen More articles by this author Expand All Advertisement PDF downloadLoading ...