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

NCT05591053 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-02-21

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

ActivSight

Use of ActivSight in patients undergoing laparoscopic or robot assisted esophagectomy.

Sponsors & Collaborators

  • University of Pittsburgh Medical Center

    collaborator OTHER

  • West Penn Allegheny Health System

    collaborator OTHER

  • Activ Surgical

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2025-01-31
Completion
2025-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05591053 on ClinicalTrials.gov