Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date February 2021
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03281707 - NIRS and DO2i Correlation N/A
Completed NCT03001531 - Safety and Tolerance of Local Heat Application in the Paralyzed Area of Patients With Complete Paraplegia N/A
Recruiting NCT05492968 - The Effect of Epinephrine, Norepinephrine and Phenylephrine on Intraoperative Hemodynamic Performance Phase 4
Completed NCT04144166 - Evaluation of Capillary Refill Index
Completed NCT04081974 - Prevalence and Predictors of Distal Limb Ischemia in Minimally Invasive Cardiac Surgery.
Recruiting NCT03747731 - A Non-invasive Evaluation of Kidney-Lung Interactions
Recruiting NCT06254833 - Microdosing ICG for Serial Colonic Perfusion Study During Surgery N/A
Completed NCT03711916 - Post-Operative Outcomes of Low Thermal Dissection vs. Traditional Electrosurgery N/A
Not yet recruiting NCT06077396 - Does Radial Artery Cannulation Affect the Perfusion Index(PI) of the Hand in Liver Transplant Operations? N/A
Not yet recruiting NCT04907071 - Intravascular Ultrasound for the Evaluation of Malperfusion Syndrome in the Setting of Acute Aortic Dissection N/A
Recruiting NCT04424069 - OCTA Analysis of Macular and Papillary Perfusion After Refractive Surgery in Myopes N/A
Recruiting NCT05276167 - Hyperthermic Intravesical Perfusion for Muscle-invasive Bladder Urothelial Carcinoma N/A
Terminated NCT03715270 - Evaluation of Tissue Oxygen Levels During Breast Reconstruction With a New Surgical Device
Terminated NCT03716050 - The Effect of Nitroglycerin Ointment, Fluorescent Angiography, and Incisional Negative Pressure Wound Therapy on Mastectomy Skin Flap Perfusion-Related Problems Phase 2/Phase 3
Recruiting NCT06019546 - PErfusion QUality ODds
Recruiting NCT04929873 - Clinical Study of VA-ECMO Remote Limb Re-perfusion Monitoring Technology N/A
Recruiting NCT06047158 - Effects of Omega-3 Fish Oil Fat Emulsion on Rehabilitation and Immune Function After Radical Surgery Combined With Intraperitoneal Hyperthermic Infusion Chemotherapy in Patients With Locally Advanced Gastric Cancer
Active, not recruiting NCT05517044 - The Pre-acclimatization Augmented Extreme Altitude Expedition N/A
Terminated NCT03843307 - Avazzia-University of Texas Southwestern Medical Center-Tennant Biomodulator® PRO Perfusion Study N/A
Completed NCT06405282 - Weightlessness Associated Cephalad Fluid Shifts; The Potential to Evaluate Venous and Lymphatic Dysfunction