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Also known as Indocyanine Green (ICG)
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 being studied as a near infrared fluorescence cholangiography agent during cholecystectomy in patients with acute cholecystitis. It is used to help visualize the biliary ducts during surgery. The agent is also known as Indocyanine Green (ICG).
Indocyanine Green is being developed by Stryker Corporation, which trades under the ticker SYK. The company is evaluating the agent in a Phase 1 clinical trial for use during cholecystectomy in patients with acute cholecystitis.
Indocyanine Green is in Phase 1 clinical development for acute cholecystitis. It is investigational and has not been approved by the FDA for this indication. The Phase 1 trial has been completed.
Indocyanine Green has been studied in one clinical trial, NCT02070627, titled Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy -- Use in Acute Cholecystitis Sub-Study. The trial was a completed Phase 1 study that enrolled 6 participants in the United States.
Yes, Indocyanine Green is also known as Indocyanine Green (ICG). ICG is the common abbreviation for the same agent. Both names refer to the same small molecule being developed by Stryker Corporation for use in acute cholecystitis.