Safety and Feasibility of ActivSightTM Laser speckle imaging in visualization of tissue perfusion and critical structures in human SAFETY AND FEASIBILITY OF ACTIVSIGHTTM LASER SPECKLE IMAGING IN VISUALIZATION OF TISSUE PERFUSION AND CRITICAL STURCTURES IN HUMAN Principal Investigator: Erik Wilson MD1 Associate Investigators: Shinil Shah DO FACS Peter C W Kim MD CM, PhD 2 Investigational Device: ActivSightTM Laser Speckle Imaging Protocol #: ACF0032020 Device: Activ Surgical Inc. Laser Speckle Imaging System Version Date: July 1 2020, V12 1 University of Texas Houston Department of Surgery 2Activ Surgical Inc 840 Summer Street Suite 108 Boston, MA 02127 Phone: 617-333-8162 Ext 400 FAX: 617-9821-0208 E-mail:
[email protected] IRB NUMBER: HSC-MS-20-0967 1 IRB APPROVAL DATE: 10/21/2020 Proprietary and Confidential Safety and Feasibility of ActivSightTM Laser speckle imaging in visualization of tissue perfusion and critical structures in human PRECIS Background: ● The integrity of vasculature and tissue perfusion at the operative site remains a critical local determinant in expectant tissue healing, avoiding complications and ensuring good clinical outcome. Today, the most commonly used method of assessing vascularity and tissue perfusion intraoperatively however continues to be a simple visual inspection of tissue by naked human eyes guided by recall and experience regardless of surgical approach, MIS or open. ● The currently available additional means of visualizing blood flow intraoperatively are limited to radiation-based fluoroscopy with X-ray contrast dye or contrast agent such as a fluorophore-based near infrared camera system. These approaches are suboptimal in effectiveness (non-real time, lacks objectivity and specificity), cumbersome to efficient workflow (need for contrast reagent preparation and injection, potential adverse allergic reactions, risk of radiation exposure and/or training requirement), and efficacious utility (need for large capital equipment, space and cost).