Spots Global Cancer Trial Database for Perfusion Assessment in Laparoscopic Left Anterior Resection
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Trial Identification
Brief Title: Perfusion Assessment in Laparoscopic Left Anterior Resection
Official Title: Open Label Clinical Study to Demonstrate the Utility of Intra-operative Perfusion Assessment Using NIR Fluorescence Angiography With the PINPOINT® Endoscopic Fluorescence Imaging System and to Assess the Impact of PINPOINT on the Surgical Decision Making Process and on Surgical Outcomes in Laparoscopic Left Anterior Resection Procedures
Study ID: NCT01560377
Interventions
Study Description
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).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Michael J Stamos, MD
Affiliation: University of California, Irvine
Role: PRINCIPAL_INVESTIGATOR
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