Perfusion Assessment in Laparoscopic Left Anterior Resection
NCT ID: NCT01560377
Last Updated: 2018-12-11
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE1
147 participants
INTERVENTIONAL
2012-05-31
2013-11-30
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Subjects Imaged with PINPOINT
Colonic tissue perfusion assessed with PINPOINT for laparoscopic left colectomy in the lower tract.
PINPOINT Endoscopic Fluorescence Imaging System
The PINPOINT system will be used to provide real-time endoscopic visible and endoscopic NIR fluorescence imaging. PINPOINT enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infra-red imaging during minimally invasive surgery
Interventions
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PINPOINT Endoscopic Fluorescence Imaging System
The PINPOINT system will be used to provide real-time endoscopic visible and endoscopic NIR fluorescence imaging. PINPOINT enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infra-red imaging during minimally invasive surgery
Eligibility Criteria
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Inclusion Criteria
* A negative pregnancy test for women of childbearing potential prior to surgery
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Novadaq Technologies ULC, now a part of Stryker
INDUSTRY
Responsible Party
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Principal Investigators
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Michael J Stamos, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Irvine
Locations
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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
Countries
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Other Identifiers
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Version 1
Identifier Type: -
Identifier Source: org_study_id