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

NCT03860493 | Completed DMC

• 1 other identifier: FLA 19-008
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Primary Objective:
2. 2.Secondary Objective:
3. 3.Evaluate the mean Assessment of handling properties using The IC- Flow versus The VITOM II.
4. 4.Evaluate the mean Surgeon preference Level using The IC- Flow tower, The IC-Flow Hand-held device versus The VITOM II.

Conditions

Skin Flap Necrosis; Perfusion; Complications

Keywords

organ perfusion; Fluorescence; icg

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• handling properties and surgeon preference level

  1 to 4 hours

Study Arms (1)

Study group

Only patients who might benefit from intraoperative fluorescent tissue perfusion assessment according to the primary surgeon will be enrolled in the study. The patients will be screened and consent during their office visit with their surgeon at the Cleveland Clinic Foundation. Each surgeon will follow the standard Open surgical protocol of his/her subspecialty, and will comply with the following additional steps according to the type of surgery:

Procedure: Perfusion evaluation with indocyanine green

Interventions

Perfusion evaluation with indocyanine green PROCEDURE

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.

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will include patients aged 18-years old and above, selected for open reconstructive surgical procedures.

You may qualify if:

• 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

You may not qualify if:

• Known allergies to iodides
• Known history of coagulopathy
• Women who are pregnant or breastfeeding, or for whom possibility of pregnancy was not ruled out

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Related Publications (4)

• 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.

  PMID: 24414461 BACKGROUND

• Alander JT, Kaartinen I, Laakso A, Patila T, Spillmann T, Tuchin VV, Venermo M, Valisuo 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.

  PMID: 22577366 RESULT

• 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.

  PMID: 21529077 RESULT

• 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.

  PMID: 19169354 RESULT

MeSH Terms

Interventions

Indocyanine Green

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Emanuele Lo Menzo, MD

  Cleveland Clinic Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 4, 2019
• Study Start: May 15, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)