Safety and Feasibility of ActivSightTM in Human

Activ Surgical

Status: Invitation-only

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

Treatments: Device: ActivSight

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04633512

ACF0012020

Details and patient eligibility

About

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).

Full 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.

Enrollment: 67 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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67 participants in 1 patient group

ActivSight Group

Experimental group

Description:

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

Treatment:

Device: ActivSight