Safety and Feasibility of ActivSightTM in Human
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- 34
Summary
- Conditions
- Acute Cholecystitis
- Colorectal Cancer
- Diverticulitis, Colonic
- Inflammatory Bowel Diseases
- Obesity Morbid
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Target enrollment is 40 patients. Feasibility will be studied under two categories of operations: feasibility in patients undergoing intestinal anastomoses for bariatric or colorectal surgery (n=26); and feasibility in patients undergoing cholecystectomy (n=14).Masking: None (Open Label)Primary Purpose: Device Feasibility
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 successf...
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 40 patients; 26 evaluating intestinal anastomoses cases (including bariatric and colorectal cases); and 14 evaluating laparoscopic cholecystectomy. Stopping rules are triggered following the first 6 patients and a comparison group 6 patients in ICG-based treatment.
Tracking Information
- NCT #
- NCT04633512
- Collaborators
- The University of Texas Health Science Center, Houston
- University of Buffalo, Buffalo General Hospital
- Investigators
- Not Provided
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