Status:
COMPLETED
Feasibility of the IC-Flow Device for Fluorescent Perfusion Evaluation During Feasibility of the IC-Flow Device
Lead Sponsor:
The Cleveland Clinic
Conditions:
Skin Flap Necrosis
Perfusion; Complications
Eligibility:
All Genders
18+ years
Brief Summary
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 KAR...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- Known allergies to iodides
- Known history of coagulopathy
- Women who are pregnant or breastfeeding, or for whom possibility of pregnancy was not ruled out
Key Trial Info
Start Date :
May 15 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03860493
Start Date
May 15 2019
End Date
December 31 2020
Last Update
February 9 2021
Active Locations (1)
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1
Cleveland Clinic Florida
Weston, Florida, United States, 33331