Safety and Feasibility of ActivSightTM in Human

Safety and Feasibility of ActivSightTM Laser Speckle Imaging in Visualization of Tissue Perfusion and Vasculature in Human

ActivSightTM combines an innovative form factor and proprietary software to deliver precise, objective, real-time visualization of blood flow and tissue perfusion intraoperatively for laparoscope-based surgery. A small adaptor that fits between any existing laparoscope and camera systems and a separate light source placed along any current commercial system will deliver objective real-time tissue perfusion and blood flow information intraoperatively.

Primary Objective: To determine safety and feasibility of ActivSightTM in displaying tissue perfusion in intestinal anastomoses including colorectal and bariatric surgery.

Secondary Objective: To determine the efficacy of ActivSightTM in; (1) displaying tissue vascularity and perfusion in comparison to indocyanine green (ICG) during gastrointestinal anastomoses; and (2) displaying biliary tree during laparoscopic cholecystectomy using ICG-based intraoperative cholangiography (IOC).

Design:

• This is a feasibility study designed to evaluate safety and feasibility of ActivSightTM in gastrointestinal anastomoses and cholecystectomy.
• Safety will be determined through clinical assessments and evaluation of any adverse event.
• Feasibility will be determined through technically successful completion of intended visualization.
• Assessment of preliminary efficacy will be performed through analysis of any intraoperative decisions made based on visual display as compared to standard endoscopic approach, or non-inferiority to ICG-based visualization and usability.
• Patients outcome and follow up to Postoperative day 28 will be monitored for clinical outcome.
• Target enrollment for the assessment of 80 patients; 52 evaluating intestinal anastomoses cases (including bariatric and colorectal cases); and 28 evaluating laparoscopic cholecystectomy. Stopping rules are triggered following the first 6 patients and a comparison group 6 patients in ICG-based treatment.

Inclusion Criteria:

• All patients age >= 18 years old undergoing laparoscopic or robot assisted intestinal anastomoses, or all patients age >= 18 years old who are planned for laparoscopic cholecystectomy; spoken command and literacy in the native language spoken at each participating center; ability to understand and follow study procedures; and having provided signed consent.
• Diagnosis:
• All patients with a clinical suspicion and diagnosis of benign or malignant, small or large bowel lesions requiring surgical resection.
• All patients with clinical suspicion and diagnosis of symptomatic cholelithiasis or cholecystitis planned for cholecystectomy.
• Typical imaging as per standard workup findings including US, CT and/or MRI. Plain radiographs and contrast imaging may be obtained by referring physicians and are helpful for confirming the clinical diagnosis.
• Any bariatric patients undergoing gastric sleeve or bypass.
• Any pediatric patient undergoing laparotomy for necrotizing enterocolitis
• Location of pathology or resected segment:
• Target lesions can be located in any fore-, mid- or hindgut segments requiring reconstruction and anastomoses.
• Prior therapy:
• Patients with prior surgery are eligible for enrollment.
• Laboratory:
• Hemoglobin > 9 g/dL
• Platelet count ≥75,000/μL (may receive transfusions)
• Normal prothrombin time, tested prothrombin, and international normalized ratio < 1.5 x upper limit of normal (ULN) (including patients on prophylactic anticoagulation)
• Renal function: Age-adjusted normal serum creatinine derived from Schwartz formula for estimating glomerular filtration rate by the Centers for Disease Control (CDC) or a creatinine clearance ≥60 mL/min/1.73 m2 for safe
• Adequate pulmonary function: Defined as no dyspnea at rest, and a pulse oximetry >94% on room air if there is clinical indication for determination.

Exclusion Criteria:

• There is no exclusion criteria for ActivSightTM for gastrointestinal resection.
• Patients assigned to FDA cleared ICG-based visualization are contraindicated for any chronic renal dysfunction, potential drug interaction, history of allergy to ICG or anaphylaxis, and pregnancy.
• Patients eligible for cholecystectomy, exclusion criteria include known allergy to iodides; known history of cholangitis, pancreatitis, prior common bile duct injury, coagulopathy or known, preexisting liver disease; pregnancy or breast-feeding; or being of reproductive age with pregnancy possible and not ruled out.
• Patients currently in any investigational agents.