Safety and Feasibility of ActivSightTM in Human

Status unconfirmed · Not applicable

Conditions studied: Acute Cholecystitis, Colorectal Cancer, Diverticulitis, Colonic, Obesity, Morbid, Inflammatory Bowel Diseases

In brief

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).

Key facts

Study ID

NCT04633512

Run by

Activ Surgical

People needed

67

Starts

2020-11-17

Expected to finish

2025-01-01

Last updated by the study team

2024-02-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Kaleida Health, University of Buffalo — Buffalo, New York, United States
• Memorial Hermann Texas Medical Center — Houston, Texas, United States
• Memorial Hermann Sugar Land Hospital — Sugar Land, Texas, United States

Full record on ClinicalTrials.gov

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