Using ActivSight™ to visualize blood flow during esophageal surgery
Utility and Usability of ActivSight™ Laser Speckle Imaging in Visualization of Tissue Perfusion and Blood Flow During Esophageal Surgery in Humans
This study is testing a new system called ActivSight™ to see if it can help doctors better visualize blood flow during esophageal surgery compared to traditional methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Activ Surgical Industry-sponsored |
| Locations | 2 sites (Pittsburgh, Pennsylvania and 1 other locations) |
| Trial ID | NCT05591053 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the ActivSight™ system, which provides real-time visualization of blood flow and tissue perfusion during laparoscopic esophageal surgery. The study aims to determine the feasibility and safety of ActivSight™ compared to traditional methods like visual inspection and ICG imaging. It involves a prospective interventional cross-over design, where patients will undergo assessments of tissue perfusion using ActivSight™ and standard practices. The trial will enroll 70 patients undergoing esophageal resection and monitor outcomes up to 28 days post-surgery.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old undergoing laparoscopic esophageal resection and reconstruction surgery.
Not a fit: Patients with conditions that do not require esophageal surgery or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this technology could enhance surgical outcomes by improving the accuracy of tissue perfusion assessments during esophageal surgeries.
How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for surgical visualization, but the specific application of ActivSight™ in this context is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Pittsburgh, Pennsylvania and 1 other locations
- University of Pittsburgh Medical Center - Dept of Cardiothoracic Surgery — Pittsburgh, Pennsylvania, United States (Recruiting)
- West Penn Hospital / Allegheny Health Network — Pittsburgh, Pennsylvania, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Peter Kim, MD
- Email: pkim@activsurgical.com
- Phone: 2023202750
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.