Safety and Feasibility of ActivSightTM in Human

Launched by ACTIV SURGICAL · Nov 11, 2020

Keywords

ClinConnect Summary

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...

Gender

ALL

Eligibility criteria

• 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.