Utility and Usability of ActivSight™ Laser Speckle Imaging in Visualization of Tissue Perfusion and Blood Flow During Esophageal Surgery in Humans

Launched by ACTIV SURGICAL · Oct 19, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging technology called ActivSight™, which helps surgeons see blood flow and tissue health during esophageal surgery. The aim is to find out if this technology can accurately show how well blood is flowing in the tissue that is being operated on, compared to traditional methods. This is important because good blood flow is crucial for healing after surgery. The trial will focus on patients undergoing laparoscopic esophageal resection and reconstruction, which is a less invasive way to remove and repair parts of the esophagus.

To participate in this trial, patients need to be at least 18 years old and scheduled for this type of surgery. They should be able to understand the study instructions and give their consent. The trial is open to both men and women, including those with previous surgeries. Participants can expect to undergo the surgery with the use of the ActivSight™ system, which will provide real-time information about their tissue health during the procedure. It’s also important to note that while there are no strict exclusion criteria for this trial, patients with certain conditions or allergies related to other imaging methods may not be eligible.

Gender

ALL

Eligibility criteria

• • INCLUSION CRITERIA
• • All patients age \> 18 years old undergoing laparoscopic esophageal resection and reconstruction surgery; 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.
• • 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.
• 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 PT, PTT and INR \< 1.5 x ULN (including patients on prophylactic anticoagulation)
• • Renal function: Age-adjusted normal serum creatinine derived from Schwartz formula for estimating GFR by the 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 esophageal surgery.
• • 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, known allergy to iodides, breast-feeding or being of reproductive age with pregnancy possible and not ruled out, and pregnancy.
• • Patients currently in any investigational agents.