Status:
COMPLETED
Fluorescent Evaluation of Colorectal Anastamoses
Lead Sponsor:
Maimonides Medical Center
Conditions:
Rectal Neoplasms
Colon Neoplasms
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
Bowel removal is indicated for various types of colon and rectal disease, including colon cancer, rectal cancer, diverticulitis, and inflammatory bowel disease among others. Following removal of the ...
Detailed Description
The purpose of this study is to evaluate whether systemically injected ICG, when fluorescing in response to NIR illumination, can assist with the assessment of perfusion at a bowel anastomotic site. T...
Eligibility Criteria
Inclusion
- Candidates for this study must meet ALL of the following inclusion criteria:
- Subject is willing and able to provide an informed consent
- Subject is willing and able to comply with the study procedures
- Subject speaks English and is able to understand the study procedures
- A pregnancy test for women of childbearing potential prior to surgery
- Subject is scheduled for laparoscopic low anterior resection
Exclusion
- Candidates for this study who meet any of the following criteria at the time of the baseline visit are NOT eligible to be enrolled in this study:
- Subject has uremia, serum creatinine \>2.5 mg/dl
- Subject has a previous history of adverse reaction or allergy to ICG, iodine, shellfish or iodine dyes
- Subjects in whom the use of x-ray dye or ICG is contraindicated including development of adverse events when previously or presently administered
- 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
- Subject is actively participating in another drug, biologic and/or device protocol
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01424293
Start Date
May 1 2010
End Date
September 1 2016
Last Update
July 13 2021
Active Locations (1)
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1
Maimonides Medical Center
Brooklyn, New York, United States, 11219