CompletedNot Applicable

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

United States6 participantsStarted 2019-05-15

Plain-language 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 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

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

Timeframe: 1 to 4 hours

Trial details

NCT IDNCT03860493

SponsorThe Cleveland Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-12-31

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