NCT04633512

Safety and Feasibility of ActivSightTM in Human

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (estimated)
• Sponsor: Activ Surgical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Acute Cholecystitis
• Colorectal Cancer
• Diverticulitis, Colonic
• Obesity, Morbid
• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
DEVICE	ActivSight	Use of ActivSight in patients undergoing laparoscopic or robot assisted intestinal anastomoses and patients undergoing laparoscopic or robot assisted cholecystectomy.

Timeline

• Start date: 2020-11-17
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2020-11-18
• Last updated: 2024-02-21

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study