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Clear Guide Medical, Inc. SBIR Phase I Award, September 2021

A SBIR Phase I contract was awarded to Clear Guide Medical in September, 2021 for $259,613.0 USD from the U.S. Department of Health & Human Services and National Institutes of Health.

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AbstractTimelineTable: Further ResourcesReferences
sbir.gov/node/2190533
Is a
SBIR/STTR Awards
SBIR/STTR Awards

SBIR/STTR Award attributes

SBIR/STTR Award Recipient
Clear Guide Medical
Clear Guide Medical
1
Government Agency
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1
Government Branch
National Institutes of Health
National Institutes of Health
1
Award Type
SBIR1
Contract Number (US Government)
1R43GM144333-011
Award Phase
Phase I1
Award Amount (USD)
259,6131
Date Awarded
September 1, 2021
1
End Date
February 28, 2022
1
Abstract

Project Summary The use of ultrasound for interventional guidance has expanded significantly over the past decade and has become an important tool in clinical specialties such as Anesthesia, Emergency Medicine and Sports Medicine. In interventional ultrasound, there are significant challenges introduced by the necessity of simultaneously visualizing the target and the needle with a single B-mode probe, keeping the nondominant hand steady while finding the correct trajectory of the needle in the dominant hand. The resulting alignment problem (probe, instrument, target) is a different skill problem than identifying structures in ultrasound and requires specialized training. Current training systems do not provide suitable information to aid the novice user in developing key hand-eye coordination skills and their retention. For this reason, we propose to design the EDU –comprised of an Interson ultrasound, a tablet computer with guidance software, a CGM Optical Head with tiny video cameras, and a CGM custom nerve block phantom-- as a learning platform for developing key skills in needle acquisition, accuracy of needle placement, and understanding needle-to-ultrasound-plane orientation. The use of tiny video cameras on the ultrasound enable computer algorithms to compute the trajectory differences between an experienced user performing one of the regional blocks and a student’s attempt. The differences between the paths to the target allow some quantification of the skills, which may be helpful in giving feedback to the student during the semester, and perhaps also to develop a benchmark for CME courses. A second aim of this proposal is to study whether learning with needle-guidance software is beneficial to student skill acquisition and/or confidence. This proposal would study a cohort of student registered nurse anesthetists during a semester course teaching five progressively more difficult nerve blocks/procedures. With this novel system, quantifiable metrics can be harnessed to demonstrate whether learning with guidance is helpful, even when the guidance is removed, and whether it can lead to more consistent procedures across students. Using proprietary custom- made phantoms, the progressive difficulty levels of the five procedures can show whether guidance can be more helpful in more difficult blocs or if it can help in all.Project Narrative The use of ultrasound for interventional guidance has expanded significantly over the past decade and has become an important tool in clinical specialties such as Anesthesia, Emergency Medicine and Sports Medicine however there are significant challenges introduced by the necessity of simultaneously visualizing the target and the needle with a single B-mode probe, keeping the nondominant hand steady while finding the correct trajectory of the needle in the dominant hand. The use of tiny video cameras on the ultrasound enable computer algorithms to compute the trajectory differences between an experienced user performing one of the regional blocks and a student’s attempt allowing some quantification of the skills, which may be helpful in giving feedback to the student during the semester, and perhaps also to develop a benchmark for CME courses. A second aim of this proposal is to study whether learning with needle-guidance software is beneficial to student skill acquisition and/or confidence by studying a cohort of student registered nurse anesthetists during a semester course teaching five progressively more difficult nerve blocks/procedures.

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