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

Completed

Conditions studied: Skin Flap Necrosis, Perfusion; Complications

In brief

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.

Key facts

Study ID

NCT03860493

Run by

The Cleveland Clinic

People needed

6

Starts

2019-05-15

Expected to finish

2020-12-31

Last updated by the study team

2021-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Cleveland Clinic Florida — Weston, Florida, United States

Full record on ClinicalTrials.gov

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