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

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.

Inclusion Criteria:

1. Patients of both genders

2. Minimum age: 18 years old

3. Spoken and written command of the language spoken in the country's center

4. Ability to understand and follow the study procedures and sign the informed consent

5. open surgical porcedures

Exclusion Criteria:

1. Known allergies to iodides

2. Known history of coagulopathy

3. Women who are pregnant or breastfeeding, or for whom possibility of pregnancy was not
ruled out