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PINPOINT Endoscopic Fluorescence Imaging System · 1 trial · 6 indications
To demonstrate the utility of intra-operative assessment of colon perfusion, using the PINPOINT System to optimize the location at which to transect the colon in laparoscopic left colectomies and to assess mucosal perfusion of the completed anastomosis following proximal anastomosis in laparoscopic left colectomy.
| Arm | Type | Description |
|---|---|---|
| Subjects Imaged with PINPOINT | EXPERIMENTAL | Colonic tissue perfusion assessed with PINPOINT for laparoscopic left colectomy in the lower tract. |
| Name | Type | Description |
|---|---|---|
| PINPOINT Endoscopic Fluorescence Imaging System | DEVICE | The PINPOINT system will be used to provide real-time endoscopic visible and endoscopic NIR fluorescence imaging. PINPOINT enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infra-red imaging during minimally invasive surgery |
Inclusion Criteria: * Subject is scheduled for laparoscopic left colectomy in the lower region (planned anastomosis located 5 - 15 cm from anal verge) * A negative pregnancy test for women of childbearing potential prior to surgery Exclusion Criteria: * Subject has a previous history of adverse r...
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PINPOINT Endoscopic Fluorescence Imaging System is used for rectal cancer, as well as colon cancer, Crohn's disease, polyp, procidentia, and diverticulitis. It is an endoscopic imaging system developed by Stryker Corporation for use in surgical procedures to assess perfusion during laparoscopic left anterior resection.
PINPOINT Endoscopic Fluorescence Imaging System is developed by Stryker Corporation, a medical technology company traded on the New York Stock Exchange under the ticker SYK. The system is designed for use in surgical procedures, particularly in the assessment of perfusion during laparoscopic left anterior resection.
PINPOINT Endoscopic Fluorescence Imaging System is in Phase 1 clinical development. It is an investigational device and has not been approved by the FDA. One Phase 1 clinical trial has been completed, involving 147 participants, to evaluate its use in surgical perfusion assessment.
PINPOINT Endoscopic Fluorescence Imaging System has one completed clinical trial, NCT01560377, titled 'Perfusion Assessment in Laparoscopic Left Anterior Resection.' This Phase 1 study enrolled 147 participants with conditions including rectal cancer, colon cancer, Crohn's disease, polyp, procidentia, and diverticulitis. The trial was conducted in the United States.
PINPOINT Endoscopic Fluorescence Imaging System is not FDA approved. It is an investigational device currently in Phase 1 clinical development. A completed clinical trial has evaluated its use, but regulatory approval has not been granted.