In Vitro Evaluation of Urinary Stone Comminution with a Clinical Burst Wave Lithotripsy System
| Autor: | Jeff Thiel, Anthony Gardner, Jonathan D. Harper, Ziyue Liu, Ian Metzler, Shivani Ramesh, Mathew Sorensen, James C. Williams, Adam D. Maxwell, Barbrina Dunmire, Michael R. Bailey, Tony Chen, Bryan W. Cunitz |
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| Rok vydání: | 2020 |
| Předmět: |
Extracorporeal Shockwave Lithotripsy
medicine.medical_specialty business.industry Urology medicine.medical_treatment Urinary stone Ultrasound 030232 urology & nephrology Lithotripsy medicine.disease 03 medical and health sciences 0302 clinical medicine 030220 oncology & carcinogenesis medicine Kidney stones Ultrasonic sensor Comminution Radiology business |
| Zdroj: | J Endourol |
| ISSN: | 1557-900X 0892-7790 |
| DOI: | 10.1089/end.2019.0873 |
| Popis: | Objective: Our goals were to validate stone comminution with an investigational burst wave lithotripsy (BWL) system in patient-relevant conditions and to evaluate the use of ultrasonic propulsion to move a stone or fragments to aid in observing the treatment endpoint. Materials and Methods: The Propulse-1 system, used in clinical trials of ultrasonic propulsion and upgraded for BWL trials, was used to fragment 46 human stones (5–7 mm) in either a 15-mm or 4-mm diameter calix phantom in water at either 50% or 75% dissolved oxygen level. Stones were paired by size and composition, and exposed to 20-cycle, 390-kHz bursts at 6-MPa peak negative pressure (PNP) and 13-Hz pulse repetition frequency (PRF) or 7-MPa PNP and 6.5-Hz PRF. Stones were exposed in 5-minute increments and sieved, with fragments >2 mm weighed and returned for additional treatment. Effectiveness for pairs of conditions was compared statistically within a framework of survival data analysis for interval censored data. Three reviewers blinded to the experimental conditions scored ultrasound imaging videos for degree of fragmentation based on stone response to ultrasonic propulsion. Results: Overall, 89% (41/46) and 70% (32/46) of human stones were fully comminuted within 30 and 10 minutes, respectively. Fragments remained after 30 minutes in 4% (1/28) of calcium oxalate monohydrate stones and 40% (4/10) of brushite stones. There were no statistically significant differences in comminution time between the two output settings (p = 0.44), the two dissolved oxygen levels (p = 0.65), or the two calyx diameters (p = 0.58). Inter-rater correlation on endpoint detection was substantial (Fleiss' kappa = 0.638, p |
| Databáze: | OpenAIRE |
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