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

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

NCT ID: NCT05591053

Condition: Esophagus Cancer
Esophageal Cancer
Esophageal Neoplasms
Esophageal Diseases
Esophageal Adenocarcinoma
Esophageal Squamous Cell Carcinoma
Esophagus SCC
Esophagus Tumor
Esophagus Adenocarcinoma
Esophagus Neoplasm

Conditions: Official terms:
Neoplasms
Adenocarcinoma
Esophageal Neoplasms
Esophageal Squamous Cell Carcinoma
Esophageal Diseases

Conditions: Keywords:
laparoscopic
robot assisted surgery
gastrointestinal anastomoses
esophagectomy
esophageal surgery
thoracic surgery
alimentary surgery
perfusion
indocyanine green (ICG)
laser speckle contrast imaging (LSCI)
cancer
minimally invasive surgery (MIS)

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Target enrollment for the assessment of esophageal anastomoses is a total of 70 patients powered to detect ~ 2-3 cm discordance between ICG and LSCI lines of demarcation between well vascularized and less vascularized site in the gastric conduit. Since ActivSight™ can detect the difference of > 2 cm between perfused versus less perfused in comparison to ICG with 80 % confidence at p<0.05 in a sample size of n = 21, the investigators estimate that the study will require an accrual of 63 patients. With potential unforeseen dropout and mortality, the investigators recruit a total of 70 patients for the proposed study.

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: ActivSight
Description: Use of ActivSight in patients undergoing laparoscopic or robot assisted esophagectomy.
Arm group label: ActivSight Group

Summary: ActivSight™ 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 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.

Detailed description: Design: - This is a prospective interventional cross-over study where ActivSight™ will be used in sequence to the standard practice of visualizing perfusion status of the conduit using the naked eye visual inspection and ICG during esophageal resection. - Feasibility will be determined by technically successful completion of intended visualization. - Safety will be determined through clinical assessments and evaluation of any adverse event. - 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. - Patient outcome and follow up to Postoperative day 28 will be monitored for clinical outcome. - Target enrollment for the assessment of esophageal anastomoses is a total of seventy patients powered to detect ~ 2-3 cm discordance between ICG and LSCI lines of demarcation between well vascularized and less vascularized sites in the gastric conduit. Since ActivSight™ can detect the difference of > 2 cm between perfused versus less perfused in comparison to ICG with 80 % confidence at p<0.05 in a sample size of n = 21, the investigators estimate that the study will require an accrual of 63 patients. With potential unforeseen dropout and mortality, the investigators will recruit a total of 70 patients for the proposed study.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: University of Pittsburgh Medical Center - Dept of Cardiothoracic Surgery

Address:
City: Pittsburgh
Zip: 15213
Country: United States

Status: Recruiting

Contact:
Last name: Julie Ward, RN, BSN

Phone: 412-647-8583
Email: wardj@upmc.edu

Investigator:
Last name: Inderpal S Sarkaria, MD
Email: Principal Investigator

Investigator:
Last name: James D Luketich, MD
Email: Sub-Investigator

Facility:
Name: West Penn Hospital / Allegheny Health Network

Address:
City: Pittsburgh
Zip: 15224
Country: United States

Status: Not yet recruiting

Contact:
Last name: Meredith Schwarz, RN, MSN

Investigator:
Last name: Blair A Jobe, MD
Email: Principal Investigator

Investigator:
Last name: Kirsten Newhams, MD, MPH
Email: Principal Investigator

Start date: April 1, 2023

Completion date: January 2025

Lead sponsor:
Agency: Activ Surgical
Agency class: Industry

Collaborator:
Agency: University of Pittsburgh Medical Center
Agency class: Other

Collaborator:
Agency: West Penn Allegheny Health System
Agency class: Other

Source: Activ Surgical

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05591053