Safety and Feasibility of ActivSightTM in Human

NCT04633512 | Enrolling By Invitation FDA Device

• 1 other identifier: ACF0012020
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 3

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).

Conditions

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

Keywords

laparoscopic; robot assisted surgery; gastrointestinal anastomoses; cholecystectomy; colorectal surgery; bariatric surgery; vascularity; perfusion; ICG; laser speckle contrast imaging

Outcome Measures

Primary Outcomes (7)

• 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

• 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

Secondary Outcomes (3)

• Ability of ActivSightTM to display perfusion.

  1 day

• Ability of ActivSightTM to display blood vessels.

  1 day

• Ability of ActivSightTM to display biliary tree.

  1 day

Study Arms (1)

ActivSight Group

EXPERIMENTAL

Patients undergoing intestinal anastomoses (colorectal and bariatric) with ActivSight (n=52) Patients undergoing cholecystectomy with ActivSight (n=28)

Device: ActivSight

Interventions

ActivSight DEVICE

Use of ActivSight in patients undergoing laparoscopic or robot assisted intestinal anastomoses and patients undergoing laparoscopic or robot assisted cholecystectomy.

ActivSight Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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 currently in any investigational agents.

Sponsors & Collaborators

• Activ Surgical: lead
• The University of Texas Health Science Center, Houston: collaborator
• University at Buffalo: collaborator
• Ohio State University: collaborator

Study Sites (3)

Kaleida Health, University of Buffalo

Buffalo, New York, 14203, United States

Location

Memorial Hermann Texas Medical Center

Houston, Texas, 77030, United States

Location

Memorial Hermann Sugar Land Hospital

Sugar Land, Texas, 77479, United States

Location

MeSH Terms

Conditions

Cholecystitis, Acute; Colorectal Neoplasms; Diverticulitis, Colonic; Obesity, Morbid; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Diverticulitis; Diverticular Diseases; Gastroenteritis; Diverticulosis, Colonic; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Target enrollment is 80 patients. Feasibility will be studied under two categories of operations: feasibility in patients undergoing intestinal anastomoses for bariatric or colorectal surgery (n=52); and feasibility in patients undergoing cholecystectomy (n=28).

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 18, 2020
• Study Start: November 17, 2020
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

US (3)