Perfusion Assessment in Laparoscopic Left Anterior Resection

Phase 1

Completed

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

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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Subjects Imaged with PINPOINT	PINPOINT Endoscopic Fluorescence Imaging System	Colonic tissue perfusion assessed with PINPOINT for laparoscopic left colectomy in the lower tract.

Primary Outcome Measures

Name	Time	Method
PINPOINT System Utility in Left Colectomy Surgery	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 Outcome Measures

Name	Time	Method
Safety of the PINPOINT System	Through hospital discharge or at 30 days post procedure, whichever is later	To assess safety related outcomes of the laparoscopic left colectomies with intra-operative assessment of perfusion using the PINPOINT Endoscopic Fluorescence Imaging System for guidance.

Locations (11): University of California San Francisco
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San Francisco, California, United States
Ochsner Medical Center
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New Orleans, Louisiana, United States
Cleveland Clinic Florida
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Weston, Florida, United States
Beth Israel Medical Center
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New York, New York, United States
University of California, Irvine
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Orange, California, United States
Maimonides Medical Center
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Brooklyn, New York, United States
Mayo Clinic
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Rochester, Minnesota, United States
Weill Cornell Medical College
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New York, New York, United States
University of Southern California
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Los Angeles, California, United States
University of California San Diego
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San Diego, California, United States
University Hospital Case Medical Center
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Cleveland, Ohio, United States