Skip to main content
OpenTrials
Completed

NCT Number: NCT03860493

Feasibility of the IC-Flow Device for Fluorescent Perfusion Evaluation During Feasibility of the IC-Flow Device

1. Primary Objective:

Demonstrate that the IC-Flow Imaging device with Indocyanine Green (ICG) is a feasible technique when visualizing and identifying perfusion of organs when compared to The KARL STORZ VITOM II ICG System during open reconstructive surgical procedures 2. Secondary Objective:

1. Evaluate the mean Assessment of handling properties using The IC- Flow versus The VITOM II. 2. Evaluate the mean Surgeon preference Level using The IC- Flow tower, The IC-Flow Hand-held device versus The VITOM II.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Skin Flap Necrosis Perfusion; Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

About this study

Currently, there is no literature that supports the clinical application of the IC-Flow. However, we intend to perform this pilot study to determine safety and feasibility of said device in comparison to its homologue, FDA-approved VITOM II ICG System.

The device named The KARL STORZ VITOM II ICG System is an imaging system used in capturing and viewing fluorescent images. The system is FDA approved for all the indications that are going to be used in our study as well as the specialties involved It is composed of an open field multidirectional imaging arm and head, a light guide and a video processor/illuminator (FDA 510 (k) K171238, May 25, 2017).

As indicated by the Department of Health and Human Services from the FDA, the indications for use are the following: "The system is used in capturing and viewing fluorescence images for the visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures." And "The system is intended to provide fluorescence images for the visual assessment of blood flow in vessels and related tissue perfusion during gastrointestinal procedures." Based on the information provided by the FDA, the device has no direct nor indirect effect on patients. Furthermore, the device predicts a safe use and it's intended to provide imagery feedback alone.

There is few clinical trials which broadly exemplify the alternate applications of ICG fluorescence as a diagnostic tool for intraoperative anatomical identification, in terms of structure, perfusion, and tissue viability. No significant increase of risks or dye-associated complications had been reported.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of both genders
  • Minimum age: 18 years old
  • Spoken and written command of the language spoken in the country's center
  • Ability to understand and follow the study procedures and sign the informed consent
  • open surgical porcedures

Exclusion criteria

  • Known allergies to iodides
  • Known history of coagulopathy
  • Women who are pregnant or breastfeeding, or for whom possibility of pregnancy was not ruled out

Treatment and study plan

Perfusion evaluation with indocyanine green

Procedure
  • At least 10 minutes before surgery, will receive a weight-scaled dose of indocyanine green by IV and the time of administration and any adverse reactions will be recorded. The Surgeon/researcher will visualize and record the images given by the KARL STORZ VITOM II ICG System and the IC-Flow camera.
  • The surgery will proceed as planned pre-operatively. The surgeon will conduct the surgery under white light and will categorize initial visualization of the organs.

Primary outcomes

  1. Perfusion with The KARL STORZ VITOM II ICG and IC-FLow System

    Time frame: 1 to 4 hours

    The vascular perfusion of the tissue studied will be analyzed using the infra red light after injection of indocyanine green (ICG) by using both the Karl Storz Vitom II and the IC-Flow systems.

Secondary outcomes

  1. handling properties and surgeon preference level

    Time frame: 1 to 4 hours

    The images attained from the two systems (Vitom II vs. IC-Flow) will be evaluated. Also the handling properties of the two devices (ease to use, portability, set up, hardware, etc) will be evaluated.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Feasibility of the IC-Flow Device for Fluorescent Perfusion Evaluation During Open Surgical Procedures

Acronym: IC-Flow

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 4, 2019
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.