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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Objective: To determine the feasibility of ActivSight™ in detecting and displaying tissue perfusion and blood flow in the conduit and foregut anastomoses in esophageal resection/reconstructive surgery. The investigators will compare the precision and accuracy among the naked eye inspection, ICG and LSCI in assessing the vascularity of the conduit.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ 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.

Locations
United States
Pennsylvania
University of Pittsburgh Medical Center - Dept of Cardiothoracic Surgery
RECRUITING
Pittsburgh
West Penn Hospital / Allegheny Health Network
NOT_YET_RECRUITING
Pittsburgh
Contact Information
Primary
Peter Kim, MD
pkim@activsurgical.com
2023202750
Backup
Chris McCulloh, MD
cmcculloh@activsurgical.com
617-333-8162
Time Frame
Start Date: 2023-04-01
Estimated Completion Date: 2025-01
Participants
Target number of participants: 70
Treatments
Experimental: ActivSight Group
Patients undergoing esophagectomy with ActivSight (n=70)
Related Therapeutic Areas
Sponsors
Leads: Activ Surgical
Collaborators: West Penn Allegheny Health System, University of Pittsburgh Medical Center

This content was sourced from clinicaltrials.gov