IGI TECHNOLOGIES, INC — Department of Health and Human Services STTR Phase II: 102

Description

The overall objective of the proposed research is to develop and conduct clinical translation of a novel visualization technology that provides minimally invasive surgeons the ability to visualize normally invisible internal anatomy together with organ surfacesThe technology addresses a long standing need in minimally invasive laparoscopic surgery to see inside and around a structure before dissectinga need that currently used laparoscopeseven when high definition and stereoscopiccannot meetWe plan to achieve our objective by integratingreal time surgical imaging modalitiesreal time laparoscopic video that shows the surface viewandlaparoscopic ultrasound capable of visualizing internal structuresWe call the resulting visualization capability augmented realityARin which laparoscopic videothe realityis augmented with ultrasound findingsespecially the tumors and the blood vesselsChildren s National Medical Center and IGI Technologies combined their complementary expertise in Phase I to demonstrate the technical feasibility of a compactaccurate and clinically viable AR visualization systembased on electromagneticEMtrackingThe two performance milestonespertaining to system s registration accuracy and interactivitywere metWe now propose developing a fully integratedclinical system and performing its preclinical and clinical evaluation in Phase IITo perform a thorough evaluation of the technology and to cater to the entire surgical marketnecessary for commercial successwe have expanded the partnership to include an adult surgical center in University of Pittsburgh Medical CenterOverallthe specific aims of the proposed research are toconvert the EM tracking based Phase I prototype to a clinical AR visualization systemevaluate the system performance through animal studiesandconduct preliminary clinical demonstration of AR visualizationThese aims are designed to fully develop a clinical AR visualization system and then conduct its preclinical and clinical demonstration and validationThe Phase II results should allow us to obtain investigational device exemption designation from the FDA for multi center clinical trials in a follow on phaseSuccessful completion of the proposed research will create a smart surgical visualization system that promises to provide surgeons greater confidenceminimize complicationsshorten procedure timesreduce blood lossand help expand the utilization of minimally invasive surgeries to beyond their current share of all surgeriesThe anticipated benefits will apply equally to pediatric and adult surgery