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PINPOINT System · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | ICG administered 10 minutes prior to time of visualization |
| Group 2 | EXPERIMENTAL | ICG administered 45 min prior to time of visualization |
| Name | Type | Description |
|---|---|---|
| PINPOINT System | DEVICE | - |
Inclusion Criteria: To be eligible for the study, subjects must fulfill all of the following criteria: 1. Subjects who are healthy men or women 18 years of age or older. 2. Subjects who are scheduled for laparoscopic biliary or hepatic operations. 3. Subjects who sign an approved informed consent ...
The PINPOINT System is an endoscopic fluorescence imaging system used to visualize biliary anatomy during laparoscopic biliary and hepatic operations. It is being studied to optimize imaging in these procedures. The system is developed by Stryker Corporation and is currently in early clinical development.
Stryker Corporation (NYSE: SYK) develops the PINPOINT System. The company is conducting clinical research on the imaging system for use in visualizing biliary anatomy during laparoscopic biliary and hepatic operations. The system is currently in early-phase clinical development.
The PINPOINT System is in early Phase 1 clinical development. One early-phase trial has been completed, which was a pilot dosing and timing study to optimize imaging during laparoscopic biliary and hepatic operations. The system is investigational and not yet approved.
The PINPOINT System has one completed clinical trial, NCT02070068, titled "A Pilot Dosing and Timing Study to Optimize Imaging When Utilizing Endoscopic Fluorescence Imaging System During Laparoscopic Biliary and Hepatic Operations." This early Phase 1 study enrolled 38 participants in the United States.
The PINPOINT System is not FDA approved. It is an investigational device currently in early Phase 1 clinical development. A single early-phase trial has been completed to study its use in imaging biliary anatomy during laparoscopic biliary and hepatic operations.