The VISION Study
A Single Arm, Prospective, Open Label, Multicenter Study Assessing Efficacy and Utility of ActivSight™ in Left-Sided Colectomy
The VISION Study is a prospective, multicenter, single-arm, open-label clinical investigation designed to evaluate the efficacy and clinical utility of the ActivSight™ Intraoperative Imaging System during elective left-sided colorectal surgery. The study aims to assess the ability of ActivSight’s laser speckle contrast imaging (LSCI) technology to provide real-time intraoperative assessment of tissue perfusion and to compare its performance, concordance and discordance rates, with indocyanine green (ICG) fluorescence angiography, the current standard adjunct for perfusion assessment.
Study Overview
Why This Study Matters
Anastomotic leak remains one of the most serious complications following colorectal surgery and is frequently associated with inadequate tissue perfusion. Although surgeons currently rely on clinical judgment and, in many cases, indocyanine green (ICG) fluorescence angiography, each method has inherent limitations.
The VISION Study seeks to evaluate whether continuous, dye-free LSCI can provide additional information that complements current intraoperative assessment techniques and supports surgical decision-making
Study Objectives
The primary objective of the VISION Study is to evaluate and compare the clinical utility of Indocyanine Green (ICG) fluorescence angiography and Laser Speckle Contrast Imaging (LSCI) in assessing intraoperative tissue perfusion at the anastomotic site during left sided resection.
Study Design
The VISION Study is a prospective, multicenter, within-patient comparison enrolling approximately 150 adult participants undergoing elective left-sided colorectal surgery. Each participant serves as their own control by undergoing intraoperative perfusion assessment with both LSCI and ICG fluorescence angiography. Participants are followed for 30 days after surgery to evaluate postoperative clinical outcomes and device performance.
Participating Centers
UNLV School of Medicine
Las Vegas, NV
PI: Dr. Ovunc Bardakcioglu
Good Samaritan Medical Center
West Palm Beach, FL
PI: Dr. Eduardo Parra Davila
Medstar Health
Washington, DC
PI: Dr. Steven Wexner
Medstar Health
Washington, DC
PI: Dr Brian Bello
Medstar Health
Washington, DC
PI: Dr. Marcus Oosenbrug
Peidmont Health
Macon, GA
PI: Dr. Sam Attalah
USC Keck School of Medicne
Los Angeles, CA
PI: Dr. Joongho Shin
Orlando Regional Medical Center
Orlando, FL
PI: Dr. Antonio Caycedo
Amsterdam UMC
Amsterdam, The Netherlands
PI: Dr. Roel Hompes
Quironsalud Sagrado Corazon Hospital
Seville, Spain
PI: Dr. Salvadore Morales-Conde