Open Label Clinical Study to Demonstrate the Utility of Intra-operative Perfusion Assessment Using NIR Fluorescence Angiography With the PINPOINT® Endoscopic Fluorescence Imaging System and to Assess the Impact of PINPOINT on the Surgical Decision Making Process and on Surgical Outcomes in Laparoscopic Left Anterior Resection Procedures
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Rectal Cancer
- Sponsor
- Novadaq Technologies ULC, now a part of Stryker
- Enrollment
- 147
- Locations
- 11
- Primary Endpoint
- PINPOINT System Utility in Left Colectomy Surgery
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to demonstrate that NIR fluorescence angiography using the PINPOINT Endoscopic Fluorescence Imaging System ("PINPOINT System" or "PINPOINT") can assess viability of colon tissue during laparoscopic left colectomy. This information will provide the surgeon with clinically relevant information in assessing whether or not the tissue has adequate blood supply in the lower section of the colon prior to a colectomy.
Detailed Description
Colectomy is a surgical procedure in which a part or all of the colon is removed. It is used to treat a variety of diseases including colon cancer, diverticulitis, inflammatory bowel disease (including ulcerative colitis or Crohn's disease) and infarcted bowel. This study is the second phase of a three phase process to demonstrate the clinical utility of perfusion assessment by NIR fluorescence angiography in colectomy. The initial phase (Phase I) consisted of a number of small investigative studies that have now been completed. Upon successful completion of this study, it is anticipated that a prospective, multi center, randomized trial will be conducted (Phase III). Information learned from this present study will help guide the design of the randomized trial e.g. specific patient populations that may best benefit from this imaging modality and how randomization should be conducted (e.g. imaged cohort vs. non imaged, or all subjects imaged but then randomized to no image assessment in one arm of the study).
Investigators
Eligibility Criteria
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 reaction or known allergy to ICG, iodine or iodine dyes
- •Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
- •Subject is a pregnant or lactating female
Outcomes
Primary Outcomes
PINPOINT System Utility in Left Colectomy Surgery
Time Frame: Day of Operation - Day 1
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.
Secondary Outcomes
- Safety of the PINPOINT System(Through hospital discharge or at 30 days post procedure, whichever is later)