Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Activ Surgical
With
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.
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
