Development of the UC Irvine force sensor results in the safe passage of ureteral access sheaths during ureteroscopic stone removal – reducing the incidence of significant ureteral damage from 23% to 0% while providing urologists the ability to safely place a larger access sheath thereby increasing the success of stone removal procedures. Ralph Clayman and the Curiosity and Innovation Lab Team worked with UCI engineers to create a novel force sensor and have used this in over 200 ureteroscopic procedures. The sensor has allowed stone cases to be done with no ureteral injuries. This is a major accomplishment as access sheath use during ureteroscopic procedures is very helpful, but is associated with some risk of ureteral injury. The team’s device assures that surgeons can safely perform ureteroscopy without the risk of ureteral injury. This is a high impact finding as 9% of the US population has stone disease. Manuscript is submitted.
Open Clinical Research Studies
a. 2016-3302 Novel Sensor to Measure Force during Ureteral Access Sheath Deployment
b. 2020-5806 Sequential Dilation and Sizing of Ureters using a Force Sensor
Awards for Project
2019 Applied Innovation – UC Irvine – Device Design award to Dr. Ralph Clayman and Kam Kaler (Dept. of Urology) and Dr. Michael Klopfer CalIT2) for the Force Sensor for measuring force during passage of an ureteral access sheath.
Kaler KS, Lama DJ, Safiullah S, Patel RM, Klopfer M, Li GP, Landman J, Clayman RV: Ureteral Access Sheath Deployment: How Much Force Is Too Much? Initial Studies with a Novel Ureteral Access Sheath Force Sensor in the Porcine Ureter. J. Endourol.: 33 (9): 712-718, 2019 https://pubmed.ncbi.nlm.nih.gov/31161788/
We have received nearly $100,000 in support for our studies with regard to ureteral dilation and use of the force sensor to determine the maximum attainable diameter of the ureter at a given force. This work has implications for the safe passage of ureteral access sheaths during ureteroscopic procedures and implications with regard to the need for stent placement, the development of larger size access sheaths, and the expansion of ureteroscopy to the treatment of larger stones thereby decreasing the need for percutaneous stone removal with its attendant higher morbidity. A clinical study with 200 patients has recently been completed and the manuscript is ready for submission to a peer review journal. Meanwhile there are two ongoing trials with the force sensor: 1.) a laboratory study to assess the maximum safe size to which a porcine ureter can be dilated after a week with an indwelling stent and 2.) a clinical study to assess the maximum to which the human ureter can safely be dilater.
In this study involving 200 patients with blood in the urine, individuals were randomized to either conventional triple CT or a regimen in which only two sets of CT images were obtained. A 33% reduction in radiation dose was achieved without impairing the physician’s ability to diagnose the underlying condition leading to blood in the urine. These findings may well change the approach to this very common urological condition. The reduction in radiation is very important as we currently know that about 1-2% of call cancers in the US are engendered by imaging-based radiation. The manuscript has been favorably reviewed by the Journal of Urology and is pending revisions.
Publications Submitted: (Journal of Urology)
Comparison of Conventional and Triple Bolus Computed Tomography Urography Protocols for Radiation Dose Reduction in Hematuria Evaluation: A Open Clinical Research
Authors: Karani R, Sung JM, Xie L, Arada RB, Parkhomenko E, Lama DJ, Lee S, Houshyar R, Lall C, Okhunov Z, Jiang P, Tapiero S, Patel RM, Clayman RV, and Landman J
Open Clinical Research
2015-2027 Prospective, Randomized Comparison of conventional and Triple Bolus CT Urography Protocols in the Management of Hematuria
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