CompletedPhase 1

Perfusion Assessment in Laparoscopic Left Anterior Resection

United States147 participantsStarted 2012-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

PINPOINT System Utility in Left Colectomy Surgery

Timeframe: Day of Operation - Day 1

Trial details

NCT IDNCT01560377

SponsorNovadaq Technologies ULC, now a part of Stryker

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-10

Results submitted2017-07-28

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