The Use of Indocyanine Green to Visualize Blood Flow to the Gastrojejunostomy During Bariatric Surgery.

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

January 25, 2023

Primary Completion Date

July 3, 2027

Study Completion Date

July 3, 2027

Conditions
Ulcer, GastricObesity, Morbid
Interventions
DRUG

Indocyanine green

Indocyanine green (ICG) is a safe, sterile, water-soluble molecule that binds to plasma proteins and can be injected intravenously. ICG will be injected intravenously based on the patient's weight prior to and after making the GJ anastomosis and a 10 mL bolus of normal saline will be immediately followed the injection of indocyanine green by an anesthesiologist. A subjective score of 1-5 for perfusion will be assigned by operating surgeons. The RYGB will then be completed by the operating surgeon in their routine fashion.

DEVICE

Stryker 1688 AIM system

The Stryker 1688 AIM system used during laparoscopic surgery which is sensitive in the visible and infrared spectrum. ICG (SPY AGENT™ GREEN) is used with the SPY mode in the Stryker 1688 AIM fluorescence imaging system to perform intraoperative fluorescence angiography.

Trial Locations (1)

M5T2S8

Toronto Western Hospital, University Health Network, Toronto

All Listed Sponsors
collaborator

Stryker Endoscopy

INDUSTRY

lead

University Health Network, Toronto

OTHER