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Indocyanine Green · 1 trial · 2 indications
Adverse events related to the use of ICG from the time of injection through the initial post-operative clinic visit will be recorded and assessed.
Anatomic identification with near-infrared fluorescence cholangiography and standard of care intraoperative cholangiography (IOC) will be used to calculate a 95% confidence interval for the effectiveness of this modality.
The time it takes to perform near infrared fluorescence cholangiography and standard of care intraoperative cholangiography will be compared.
| Arm | Type | Description |
|---|---|---|
| NIRF-C and IOC | EXPERIMENTAL | Each enrolled subject will undergo injection with indocyanine green (ICG), intraoperative near infrared fluorescence cholangiography (NIRF-C) and standard of care intraoperative cholangiography. |
| Name | Type | Description |
|---|---|---|
| Indocyanine Green (ICG) | DRUG | 60-30 minutes prior to cholecystectomy, 2.5 mg of indocyanine green (ICG) will be injected intravenously. An additional 2.5 mg of ICG may be injected intraoperatively if the fluorescence fades prior to imaging. |
| Near Infrared Fluorescence Cholangiography (NIRF-C) | DEVICE | Near infrared fluorescence cholangiography will be performed intraoperatively in order to image anatomy. |
Inclusion Criteria: * Age 18-89 * Planned laparoscopic cholecystectomy Exclusion Criteria: * Inability to provide informed consent * Pregnant * Allergy to ICG, iodine, and/or shellfish * Lactating
Indocyanine Green is a small molecule being studied for use in acute cholecystitis, a condition involving gallbladder inflammation. It is used as a fluorescent imaging agent during cholecystectomy surgery to help visualize the bile ducts. The drug is currently in Phase 1 clinical development for this indication.
Indocyanine Green is a fluorescent dye that binds to plasma proteins and emits near-infrared light when excited. This property allows surgeons to visualize biliary structures in real time during cholecystectomy, potentially reducing the risk of bile duct injury. It does not target a specific molecular receptor.
Indocyanine Green is being developed by Stryker Corporation, a medical technology company traded on the NYSE under the ticker SYK. Stryker is investigating the drug for use in acute cholecystitis as part of its surgical imaging portfolio.
Indocyanine Green is in Phase 1 clinical development for acute cholecystitis. It is an investigational drug and has not been approved by the FDA for this specific use. The drug is being studied as an imaging agent during cholecystectomy procedures.
Indocyanine Green has one completed Phase 1 clinical trial, NCT02070627, titled "Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy -- Use in Acute Cholecystitis Sub-Study." The trial enrolled 6 participants in the United States and was an uncontrolled, non-randomized study.