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

NeuroTherapia, Inc.

Status: Completed

Conditions: Perfusion; Complications; Skin Flap Necrosis

Treatments: Procedure: Perfusion evaluation with indocyanine green

Study type: Observational

Funder types: Other

Identifiers

NCT03860493

FLA 19-008

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

6 participants in 1 patient group

Study group

Description:

Only patients who might benefit from intraoperative fluorescent tissue perfusion assessment according to the primary surgeon will be enrolled in the study. The patients will be screened and consent during their office visit with their surgeon at the Cleveland Clinic Foundation. Each surgeon will follow the standard Open surgical protocol of his/her subspecialty, and will comply with the following additional steps according to the type of surgery:

Treatment:

Procedure: Perfusion evaluation with indocyanine green