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). 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 Phase I SBIR proposal is to develop a virtual simulator to train clinicians to improve procedural skill competence in real-time ultrasound-guided renal biopsy. Although improvements in needle design and ultrasound imaging have been helpful, excellent biopsy technique and skill are essential to consistently obtaining high yield renal biopsy samples. Furthermore, poor renal biopsy technique can potentially lead to significant complications and adverse lethal outcomes. The simulator proposed in this project will accelerate the training of ultrasound-guided renal biopsy in a risk-free environment, ultimately improving the safety of kidney biopsy and ensuring that the biopsy procedure yields high quality specimen that can provide useful clinical information. The proposed system will benefit radiologists, nephrologists, and interventional radiologists in two ways: (a) Improved three dimensional and dynamic ultrasound imaging interpretation specific to performing a needle biopsy and (b) Improved manual dexterity in needle handling with the aid of tactile feedback. This project is a collaboration between Kitware Inc. and Children's National Medical Center. Kitware is a leader in the creation and support of state-of-the-art software and technology with more than 15 years of experience in image-guided interventions. Children's National Medical Center (CNMC) is an internationally recognized pediatric hospital with extensive expertise in the clinical management of renal pathologies. The two institutions have already collaborated successfully on several projects including image guided biopsy projects.
The aims of the Phase I project are to build the virtual simulator system and evaluate it by conducting a study with pediatric radiologists, nephrologists, and interventional radiologists at CNMC. The successful completion of the Phase I work will result in a proof of concept of our simulator system and lay the groundwork for further system development and validation in Phase II.

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 I (R43)
Project #
1R43DK115332-01
Application #
9408987
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Gossett, Daniel Robert
Project Start
2017-07-18
Project End
2018-06-30
Budget Start
2017-07-18
Budget End
2018-06-30
Support Year
1
Fiscal Year
2017
Total Cost
Indirect Cost
Name
Kitware, Inc.
Department
Type
DUNS #
010926207
City
Clifton Park
State
NY
Country
United States
Zip Code
12065