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

Perfusion; Complications Clinical Trial

— IC-Flow  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03860493
• Other study ID #: FLA 19-008
• Status: Completed
• Start date: May 15, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2021
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Necrosis
• Perfusion; Complications
• Skin Flap Necrosis

Intervention

Procedure:
• Perfusion evaluation with indocyanine green
1. At least 10 minutes before surgery, will receive a weight-scaled dose of indocyanine green by IV and the time of administration and any adverse reactions will be recorded. The Surgeon/researcher will visualize and record the images given by the KARL STORZ VITOM II ICG System and the IC-Flow camera. 3. The surgery will proceed as planned pre-operatively. The surgeon will conduct the surgery under white light and will categorize initial visualization of the organs.

Locations

Country	Name	City	State
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

References & Publications (4)

Alander JT, Kaartinen I, Laakso A, Pätilä T, Spillmann T, Tuchin VV, Venermo M, Välisuo P. A review of indocyanine green fluorescent imaging in surgery. Int J Biomed Imaging. 2012;2012:940585. doi: 10.1155/2012/940585. Epub 2012 Apr 22. — View Citation

Choi M, Choi K, Ryu SW, Lee J, Choi C. Dynamic fluorescence imaging for multiparametric measurement of tumor vasculature. J Biomed Opt. 2011 Apr;16(4):046008. doi: 10.1117/1.3562956. — View Citation

Dip FD, Asbun D, Rosales-Velderrain A, Lo Menzo E, Simpfendorfer CH, Szomstein S, Rosenthal RJ. Cost analysis and effectiveness comparing the routine use of intraoperative fluorescent cholangiography with fluoroscopic cholangiogram in patients undergoing laparoscopic cholecystectomy. Surg Endosc. 2014 Jun;28(6):1838-43. doi: 10.1007/s00464-013-3394-5. Epub 2014 Jan 11. — View Citation

Kang Y, Choi M, Lee J, Koh GY, Kwon K, Choi C. Quantitative analysis of peripheral tissue perfusion using spatiotemporal molecular dynamics. PLoS One. 2009;4(1):e4275. doi: 10.1371/journal.pone.0004275. Epub 2009 Jan 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perfusion with The KARL STORZ VITOM II ICG and IC-FLow System	The vascular perfusion of the tissue studied will be analyzed using the infra red light after injection of indocyanine green (ICG) by using both the Karl Storz Vitom II and the IC-Flow systems.	1 to 4 hours
Secondary	handling properties and surgeon preference level	The images attained from the two systems (Vitom II vs. IC-Flow) will be evaluated. Also the handling properties of the two devices (ease to use, portability, set up, hardware, etc) will be evaluated.	1 to 4 hours