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Clinical Trial Summary

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).


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04633512
Study type Interventional
Source Activ Surgical
Contact
Status Enrolling by invitation
Phase N/A
Start date November 17, 2020
Completion date January 2025

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