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Jeff Thiel

Research Scientist/Engineer II

Email

jthiel@apl.uw.edu

Education

B.S. Diagnostic Medical Ultrasound, Seattle University, 1992

Publications

2000-present and while at APL-UW

Fragmentation of stones by burst wave lithotripsy in the first 19 humans

Harper, J.D., J.E. Lingeman, R.M. Sweet, I.S. Metzler, P. Sunaryo, J.C. Williams, A.D. Maxwell, J. Thiel, B.M. Cunitz, B. Dunmire, M.R. Bailey, and M.D. Sorensen, "Fragmentation of stones by burst wave lithotripsy in the first 19 humans," J. Urol., 207, doi:10.1097/JU.0000000000002446, 2022.

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1 May 2022

We report stone comminution in the first 19 human subjects by burst wave lithotripsy (BWL), which is the transcutaneous application of focused, cyclic ultrasound pulses. This was a prospective multi-institutional feasibility study recruiting subjects undergoing clinical ureteroscopy (URS) for at least 1 stone ≤12 mm as measured on computerized tomography. During the planned URS, either before or after ureteroscope insertion, BWL was administered with a handheld transducer, and any stone fragmentation and tissue injury were observed. Up to 3 stones per subject were targeted, each for a maximum of 10 minutes. The primary effectiveness outcome was the volume percent comminution of the stone into fragments ≤2 mm. The primary safety outcome was the independent, blinded visual scoring of tissue injury from the URS video. Overall, median stone comminution was 90% (IQR 20, 100) of stone volume with 21 of 23 (91%) stones fragmented. Complete fragmentation (all fragments ≤2 mm) within 10 minutes of BWL occurred in 9 of 23 stones (39%). Of the 6 least comminuted stones, likely causative factors for decreased effectiveness included stones that were larger than the BWL beamwidth, smaller than the BWL wavelength or the introduction of air bubbles from the ureteroscope. Mild reddening of the papilla and hematuria emanating from the papilla were observed ureteroscopically. The first study of BWL in human subjects resulted in a median of 90% comminution of the total stone volume into fragments ≤2 mm within 10 minutes of BWL exposure with only mild tissue injury.

First in-human burst wave lithotripsy for kidney stone comminution: Initial two case studies

Harper, J.D., I. Metzler, M.K. Hall, T.T. Chen, A.D. Maxwell, B.W. Cunitz, B. Dunmire, J. Thiel, J.C. Williams, M.R. Bailey, and M.D. Sorensen, "First in-human burst wave lithotripsy for kidney stone comminution: Initial two case studies," J. Endourol., 35, 506-511, doi:10.1089/end.2020.0725, 2021.

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1 Apr 2021

Purpose: To test the effectiveness (Participant A) and tolerability (Participant B) of urinary stone comminution in the first in-human trial of a new technology, burst wave lithotripsy (BWL).

Materials and Methods: An investigational BWL and ultrasonic propulsion system was used to target a 7-mm kidney stone in the operating room before ureteroscopy (Participant A). The same system was used to target a 7.5 mm ureterovesical junction stone in clinic without anesthesia (Participant B).

Results: For Participant A, a ureteroscope inserted after 9 minutes of BWL observed fragmentation of the stone to < 2 mm fragments. Participant B tolerated the procedure without pain from BWL, required no anesthesia, and passed the stone on day 15.

Conclusions: The first in-human tests of BWL pulses were successful in that a renal stone was comminuted in < 10 minutes, and BWL was also tolerated by an awake subject for a distal ureteral stone.

In vitro evaluation of urinary stone comminution with a clinical burst wave lithotripsy system

Ramesh, S., T.T. Chen, A.D. Maxwell, B.W. Cunitz, B. Dunmire, J. Thiel, J.C. Williams, A. Gardner, Z. Liu, I. Metzler, J.D. Harper, M.D. Sorensen, and M.R. Bailey, "In vitro evaluation of urinary stone comminution with a clinical burst wave lithotripsy system," J. Endourol., 34, 1167-1173, doi:10.1089/end.2019.0873, 2020.

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1 Nov 2020

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 < 0.0001), with individual reviewer sensitivities of 95%, 86%, and 100%.

Conclusions: Eighty-nine percent of human stones were comminuted with a clinical BWL system within 30 minutes under conditions intended to reflect conditions in vivo. The results demonstrate the advantage of using ultrasonic propulsion to disperse fragments when making a visual determination of breakage endpoint from the real-time ultrasound image.

More Publications

Inventions

Transvaginal or Transrectal Probe for Ureter Stone Lithotripsy

Record of Invention Number: 49263

Mike Bailey, Barbrina Dunmire, Jeff Thiel

Disclosure

12 May 2021

Acoustics Air-Sea Interaction & Remote Sensing Center for Environmental & Information Systems Center for Industrial & Medical Ultrasound Electronic & Photonic Systems Ocean Engineering Ocean Physics Polar Science Center
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