Comparison of the Diagnostic Accuracy of Fujifilm Endoscopic Hypoxia Imaging (FEHI) to Indocyanine Green Fluorescein Imaging in Assessing Intraoperative Tissue Ischemia in Gastrointestinl Surgery

Overview

About this study

The aims of this study are to compare the diagnostic accuracy of FEHI, a non-invasive, non-drug, spectral imaging technology to current standard of care, ICG fluorescein imaging, with regard to intraoperative tissue ischemia, to estimate the optimal threshold value for SpO2 in FEHI to achieve optimal correlation with ICG imaging, and to compare the time needed to complete FEHI compared to ICG. These will be compared in the final 70% of cases to avoid learning curve bias on the first cases.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Subject provides informed consent and is:
- > 18 years of age;
- Deemed competent to make medical decisions.
Subject is scheduled to undergo gastrointestinal surgery as part of the standard care for management of their disease.
Patients undergoing upper or lower GI surgery where ICG imaging would normally be within the standard of care to assess tissue ischemia risk. These include:
- Sleeve gastrectomy;
- Roux-en-Y gastric bypass;
- Gastrectomy;
- Esophagectomy;
- Colectomy;
- Subject is mentally capable of understanding study procedures.

Exclusion Criteria:

Known history of allergy to ICG, iodine or shellfish.
Methemoglobinemia.
Emergency surgery.

Eligibility last updated 10/25/21. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla. Mayo Clinic principal investigator Mathew Thomas, M.B.B.S., M.D.	Closed-enrolling by invitation What is this? (?) "Close" Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.	Contact information: Clinical Studies Unit (904) 953-2255

Mayo Clinic Location

Status

Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Mathew Thomas, M.B.B.S., M.D.

Closed-enrolling by invitation

Contact information:

Clinical Studies Unit

(904) 953-2255

More information

Publications

Publications are currently not available

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