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| Name | Class |
|---|---|
| Novadaq Technologies ULC, now a part of Stryker | INDUSTRY |
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Operations on the liver, bile ducts, and gallbladders are some of the most commonly performed abdominal operations in the United States. Cholecystectomy, removal of the gallbladder, is the most common of these with more than 750,000 performed annually. Injury to the common bile duct (CBD) during these procedures occur infrequently (approximately 0.1% to 0.5%), but it is an important source of patient morbidity. Serious injuries often require at least one surgical repair, and these repairs have variable long-term outcomes. Techniques to allow the visualization of the bile ducts may prevent such an injury, by providing vital information about the presence of gallstones in the CBD and show a surgical road map of the ducts. Near-infrared (NIR) cholangiography has the advantage over standard cholangiography of not exposing patients and healthcare providers to radiation. This technique also allows the superimposition of the cholangiogram onto the normal image.
This study is being conducted to optimize an imaging technique called PINPOINT. Images will be obtained during clinically necessary operations. The images will be evaluated to determine the best method for locating and outlining the anatomy. The information learned will guide the future use of PINPOINT in laparoscopic procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | ICG administered 10 minutes prior to time of visualization |
|
| Group 2 | Experimental | ICG administered 45 min prior to time of visualization |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PINPOINT System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ease of Identification of Biliary Anatomy as Scored by the Surgeon (1-5 scale) | 10 minutes after injection | |
| Ease of Identification of Biliary Anatomy as Scored by the Surgeon (1-5 scale) | 45 minutes after injection |
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Inclusion Criteria:
To be eligible for the study, subjects must fulfill all of the following criteria:
Exclusion Criteria:
Subjects meeting any of the following criteria will be excluded from the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | United States |
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