Spots Global Cancer Trial Database for A Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection
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Trial Identification
Brief Title: A Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection
Official Title: A Randomized, Controlled, Parallel, Multicenter Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection
Study ID: NCT02205307
Study Description
Brief Summary: This is a randomized, controlled, parallel, multicenter study to determine the difference in post-operative anastomotic leak rate in low anterior resection procedures where colon and rectal tissue perfusion is evaluated using PINPOINT as an adjunct to standard surgical practice compared to surgical procedures performed according to standard surgical practice alone.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
John Muir Medical Center, Concord Campus, Concord, California, United States
Kaiser Permanente, Los Angeles, California, United States
University of California, Irvine, Orange, California, United States
University of California, San Francisco, San Francisco, California, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida, United States
University of South Florida, Tampa, Florida, United States
Cleveland Clinic Florida, Weston, Florida, United States
Rush University Medical Center, Chicago, Illinois, United States
Indiana University, Indianapolis, Indiana, United States
Ochsner Clinic, New Orleans, Louisiana, United States
Johns Hopkins, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Barnes Jewish Medical Center, Saint Louis, Missouri, United States
Sunrise Hospital and Medical Center, Las Vegas, Nevada, United States
Mount Sinai Beth Israel, New York, New York, United States
Mount Sinai Medical Center, New York, New York, United States
Weill Cornell Medical College, New York, New York, United States
The Christ Hospital, Cincinnati, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Baylor University Medical Center, Dallas, Texas, United States
Methodist Hospital, Houston, Texas, United States
Contact Details
Name: Michael J Stamos, MD
Affiliation: University of California, Irvine
Role: PRINCIPAL_INVESTIGATOR
Name: Steven Wexner, MD
Affiliation: Cleveland Clinic Florida
Role: PRINCIPAL_INVESTIGATOR
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