The objectives of the Kidney Precision Medicine Project (KPMP) project are to create a kidney tissue atlas, define disease subgroups, and identify critical cells, pathways and targets for novel therapies by obtaining and evaluating kidney biopsies from participants with acute kidney injury (AKI) and chronic kidney disease (CKD). The overall prevalence of CKD in the general population is approximately 14 percent with more than 661,000 Americans having a kidney failure. As part of this effort, there is a need for new technologies that improve the safety of the human kidney biopsy as well as the quality and diagnostic yield so that the biopsy tissue yields useful research or clinical information. Ultrasound-guided kidney biopsy is a critically important tool in the evaluation and management of renal pathologies. The goal of this project is to develop a virtual simulator to train clinicians to improve procedural skill competence in real-time ultrasound-guided renal biopsy. In our Phase I award, we developed KBVTrainer (Kidney Biopsy Virtual Trainer), a low-cost, virtual simulator for ultrasound-guided kidney biopsy training. KBVTrainer is intended to train radiologists, nephrologists, and interventional radiologists to improve procedural skill competence in real-time ultrasound-guided renal biopsy. This advanced virtual simulator for real-time ultrasound-guided renal biopsy training provided several advantages including acceleration of the training of ultrasound-guided renal biopsy in a risk-free environment to improve the safety of kidney biopsy and ensuring that the biopsy procedure yields high quality specimen. Our clinical evaluation at Children's National Medical Center (CNMC) with pediatric cases has shown that the developed system can benefit trainees in two ways: (a) Improve three dimensional and dynamic ultrasound imaging interpretation during needle biopsy and (b) Improve manual dexterity while handling the needle with the aid of tactile feedback. The Phase I project has successfully achieved its aims and provided a solid understanding of the challenges involved and the improvements needed to develop the system to explore commercialization opportunities. In this Phase II project, we will improve our technology based on the Phase I evaluation feedback, develop automated skill assessment and tracking modules that can be deployed in a web-based application, and conduct a clinical validation study with clinicians who are involved with performing pediatric and adult kidney biopsy from Children's National Medical Center (CNMC), Johns Hopkins Medical Institution (JHMI) and Georgetown University (GU).

Public Health Relevance

The Kidney Precision Medicine Project (KPM) was initiated to create a kidney tissue atlas, define disease subgroups, and identify critical cells, pathways and targets for novel therapies by obtaining kidney biopsies from participants with acute kidney injury and chronic kidney disease. Ultrasound-guided renal biopsy is a critically important tool in the evaluation and management of renal pathologies and it requires competent biopsy technique and skill to consistently obtain high yield biopsy samples. This project aims to develop a virtual simulator to train clinicians to improve procedural skill competence in real-time ultrasound-guided renal biopsy.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44DK115332-02
Application #
9843084
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Gossett, Daniel Robert
Project Start
2019-08-13
Project End
2021-07-31
Budget Start
2019-08-13
Budget End
2020-07-31
Support Year
2
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Kitware, Inc.
Department
Type
DUNS #
010926207
City
Clifton Park
State
NY
Country
United States
Zip Code
12065