Safety and Feasibility of ActivSightTM in Human

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

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Inflammatory Bowel Diseases; Colorectal Cancer; Obesity, Morbid; Diverticulitis, Colonic; Acute Cholecystitis
• Intervention / Treatment: Device: ActivSight

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.

• Study Type: Interventional
• Enrollment (Estimated): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14203
      • Kaleida Health, University of Buffalo
  • Texas
    • Houston, Texas, United States, 77030
      • Memorial Hermann Texas Medical Center
    • Sugar Land, Texas, United States, 77479
      • Memorial Hermann Sugar Land Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All patients age >= 18 years old undergoing laparoscopic or robot assisted intestinal anastomoses, or all patients age >= 18 years old who are planned for laparoscopic cholecystectomy; spoken command and literacy in the native language spoken at each participating center; ability to understand and follow study procedures; and having provided signed consent.
• Diagnosis:
• All patients with a clinical suspicion and diagnosis of benign or malignant, small or large bowel lesions requiring surgical resection.
• All patients with clinical suspicion and diagnosis of symptomatic cholelithiasis or cholecystitis planned for cholecystectomy.
• Typical imaging as per standard workup findings including US, CT and/or MRI. Plain radiographs and contrast imaging may be obtained by referring physicians and are helpful for confirming the clinical diagnosis.
• Any bariatric patients undergoing gastric sleeve or bypass.
• Any pediatric patient undergoing laparotomy for necrotizing enterocolitis
• Location of pathology or resected segment:
• Target lesions can be located in any fore-, mid- or hindgut segments requiring reconstruction and anastomoses.
• Prior therapy:
• Patients with prior surgery are eligible for enrollment.
• Laboratory:
• Hemoglobin > 9 g/dL
• Platelet count ≥75,000/μL (may receive transfusions)
• Normal prothrombin time, tested prothrombin, and international normalized ratio < 1.5 x upper limit of normal (ULN) (including patients on prophylactic anticoagulation)
• Renal function: Age-adjusted normal serum creatinine derived from Schwartz formula for estimating glomerular filtration rate by the Centers for Disease Control (CDC) or a creatinine clearance ≥60 mL/min/1.73 m2 for safe
• Adequate pulmonary function: Defined as no dyspnea at rest, and a pulse oximetry >94% on room air if there is clinical indication for determination.

Exclusion Criteria:

• There is no exclusion criteria for ActivSightTM for gastrointestinal resection.
• Patients assigned to FDA cleared ICG-based visualization are contraindicated for any chronic renal dysfunction, potential drug interaction, history of allergy to ICG or anaphylaxis, and pregnancy.
• Patients eligible for cholecystectomy, exclusion criteria include known allergy to iodides; known history of cholangitis, pancreatitis, prior common bile duct injury, coagulopathy or known, preexisting liver disease; pregnancy or breast-feeding; or being of reproductive age with pregnancy possible and not ruled out.
• Patients currently in any investigational agents.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ActivSight Group; Patients undergoing intestinal anastomoses (colorectal and bariatric) with ActivSight (n=52) Patients undergoing cholecystectomy with ActivSight (n=28)	Device: ActivSight; Use of ActivSight in patients undergoing laparoscopic or robot assisted intestinal anastomoses and patients undergoing laparoscopic or robot assisted cholecystectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability of ActivSightTM by surgeon, as quantified by Likert scale.	Likert scale ratings will serve as an outcome for feasibility. Scale 1-5 question (1=strongly disagree, 2=slightly disagree, 3=neutral, 4=slightly agree, 5=strongly agree): "ActivSightTM was easy to use while operating."	1 day
Support personnel satisfaction with ActivSightTM, as quantified by Likert scale.	Likert scale ratings will serve as an outcome for feasibility. Scale 1-5 question (1=strongly disagree, 2=slightly disagree, 3=neutral, 4=slightly agree, 5=strongly agree): "ActivSightTM was easy to set up for the procedure."	1 day
Incidence of Adverse Events in 28 days following use of ActivSightTM	To determine safety of ActivSightTM in patients undergoing intestinal anastomoses, as defined through clinical assessments and evaluation of use related adverse events intraoperatively and a routine follow up at 28 days following surgery. ActivSightTM will be deemed safe if hardware (adaptor or light source)-related major (serious) adverse event is encountered in the treated patients and if less than 2 hardware-related minor adverse events are encountered. Adverse events will be summarized descriptively and tabulations on the type, severity, and relationship to application will be performed and any changes of outcomes from baseline on follow up will be examined using the nonparametric Wilcoxon rank test.	28 days
Preparation time of ActivSightTM.	Rate on a scale of 1-5 (1 = Difficult to use or Unsatisfied - 5 = no training required or very satisfied): How easy was ActivSight to set up?	1 day
Latency of display of ActivSightTM.	Rate on a scale of 1-5 (1 = Difficult to use or Unsatisfied - 5 = no training required or very satisfied): How specifically did ActivSight display the intended field and the target tissue of interest?	1 day
Resolution of display of ActivSightTM.	Rate on a scale of 1-5 (1 = Difficult to use or Unsatisfied - 5 = no training required or very satisfied): How was the display quality of ActivSight on the intended field and target tissue of interest?	1 day
Specificity of display of ActivSightTM.	Specificity of display will serve as an outcome for feasibility. Yes/No question for surgeon: "Does the perfusion information displayed by ActivSightTM reflect the expected pattern of blood flow interruption?"	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability of ActivSightTM to display perfusion.	ActivSightTM ability to display perfusion at a tissue level during gastrointestinal anastomoses is measured by the following Yes/No question for the surgeon: "Does ActivSightTM display tissue perfusion of the anatomy during anastomoses in comparison to ICG?"	1 day
Ability of ActivSightTM to display blood vessels.	ActivSightTM ability to display blood vessels during gastrointestinal anastomoses is measured by the following Yes/No question for the surgeon: "Does ActivSightTM display vascularity of the anatomy during anastomoses in comparison to ICG?"	1 day
Ability of ActivSightTM to display biliary tree.	The clinical metrics for displaying biliary tree will be evaluated using the following question: "Which of the following biliary structures are you able to identify using ActivSightTM with ICG? (Select all that apply): common bile duct (CD), right hepatic duct (RHD), common hepatic duct (CHD), common bile duct (CBD), cystic common bile duct junction (CCBDJ), cystic gallbladder junction (CGJ), accessory ducts (AD)."	1 day

Collaborators and Investigators

• Sponsor: Activ Surgical
• Collaborators: The University of Texas Health Science Center, Houston; Ohio State University; University at Buffalo

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2020
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: October 28, 2020
• First Submitted That Met QC Criteria: November 11, 2020
• First Posted (Actual): November 18, 2020

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: bariatric surgery; colorectal surgery; cholecystectomy; ICG; laparoscopic; perfusion; laser speckle contrast imaging; robot assisted surgery; gastrointestinal anastomoses; vascularity
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Gallbladder Diseases; Biliary Tract Diseases; Diverticular Diseases; Obesity; Diverticulosis, Colonic; Inflammatory Bowel Diseases; Cholecystitis; Cholecystitis, Acute; Obesity, Morbid; Diverticulitis; Diverticulitis, Colonic
• Other Study ID Numbers: ACF0012020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No