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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01560377 | Perfusion Assessment in Laparoscopic Left Anterior Resection | PHASE1 | COMPLETED | 147 | — | — | May 1, 2012 | Nov 1, 2013 | Dec 11, 2018 | 11 | United States |
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...