Perfusion Assessment in Laparoscopic Left Anterior Resection

Completed · Phase 1

Conditions studied: Rectal Cancer, Colon Cancer, Crohn's Disease, Polyp, Procidentia, Diverticulitis

In brief

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.

Key facts

Study ID

NCT01560377

Run by

Novadaq Technologies ULC, now a part of Stryker

People needed

147

Starts

2012-05-01

Expected to finish

2013-11-01

Last updated by the study team

2018-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Southern California — Los Angeles, California, United States
• University of California, Irvine — Orange, California, United States
• University of California San Diego — San Diego, California, United States
• University of California San Francisco — San Francisco, California, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Maimonides Medical Center — Brooklyn, New York, United States
• Beth Israel Medical Center — New York, New York, United States
• Weill Cornell Medical College — New York, New York, United States
• University Hospital Case Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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