Colon Cancer Clinical Trial

Perfusion Assessment in Laparoscopic Left Anterior Resection

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.

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Full 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).

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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

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

147

Study ID:

NCT01560377

Recruitment Status:

Completed

Sponsor:

Novadaq Technologies ULC, now a part of Stryker

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There are 11 Locations for this study

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University of Southern California
Los Angeles California, 90089, United States
University of California, Irvine
Orange California, 92868, United States
University of California San Diego
San Diego California, 92093, United States
University of California San Francisco
San Francisco California, 94115, United States
Cleveland Clinic Florida
Weston Florida, 33331, United States
Ochsner Medical Center
New Orleans Louisiana, 70121, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Maimonides Medical Center
Brooklyn New York, 11219, United States
Beth Israel Medical Center
New York New York, 10003, United States
Weill Cornell Medical College
New York New York, 10021, United States
University Hospital Case Medical Center
Cleveland Ohio, 44106, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

147

Study ID:

NCT01560377

Recruitment Status:

Completed

Sponsor:


Novadaq Technologies ULC, now a part of Stryker

How clear is this clinincal trial information?

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