RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-04-01
Study Completion:2025-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05591053

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Peter Kim, MD
CONTACT
2023202750
pkim@activsurgical.com
Chris McCulloh, MD
CONTACT
617-333-8162
cmcculloh@activsurgical.com

Study Locations (Sites)

University of Pittsburgh Medical Center - Dept of Cardiothoracic Surgery
Pittsburgh, Pennsylvania, 15213
United States
West Penn Hospital / Allegheny Health Network
Pittsburgh, Pennsylvania, 15224
United States

Collaborators and Investigators

Sponsor: Activ Surgical

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-01
Study Completion Date2025-01

Study Record Updates

Study Start Date2023-04-01
Study Completion Date2025-01

Terms related to this study

Keywords Provided by Researchers

  • 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)

Additional Relevant MeSH Terms

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