Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02070627 | Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy -- Use in Acute Cholecystitis Sub-Study | PHASE1 | COMPLETED | 6 | — | — | Jul 1, 2013 | Aug 1, 2014 | Nov 3, 2014 | 1 | United States |
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