Perfusion; Complications Clinical Trial
— IC-FlowOfficial title:
Feasibility of the IC-Flow Device for Fluorescent Perfusion Evaluation During Open Surgical Procedures
NCT number | NCT03860493 |
Other study ID # | FLA 19-008 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 15, 2019 |
Est. completion date | December 31, 2020 |
Verified date | February 2021 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Florida | Weston | Florida |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic |
United States,
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
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 |
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