Ignite Creation Date:
2024-05-06 @ 3:26 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04633512
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-21
First Post:
2020-10-28
Brief Title:
Safety and Feasibility of ActivSightTM in Human
Sponsor:
Activ Surgical
Organization:
Activ Surgical
Study Overview
Official Title:
Safety and Feasibility of ActivSightTM Laser Speckle Imaging in Visualization of Tissue Perfusion and Vasculature in Human
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None