Status not kept up to date
Safety and Feasibility of ActivSightTM in Human
NCT04633512 · Activ Surgical · Updated 21 Feb 2024
- What is being tested
- ActivSight
- For
- Acute Cholecystitis; Colorectal Cancer; Diverticulitis, Colonic; Obesity, Morbid; Inflammatory Bowel Diseases
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 67 people. The full rules are on the registry page.
- Where
- United States (3 sites)
- When
- Starts or started 17 Nov 2020, ends Jan 2025. Registered 18 Nov 2020.
- Results
- None posted yet.
In the researchers' words
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).
Sites
- Kaleida Health, University of BuffaloBuffalo, New York, United States
- Memorial Hermann Texas Medical CenterHouston, Texas, United States
- Memorial Hermann Sugar Land HospitalSugar Land, Texas, United States