Ovarian Cancer Clinical Trial
A Study of Intra-operative Imaging in Women With Ovarian Cancer
Summary
The purpose of this study is to find out whether using the PINPOINT imaging system intra-operatively can reduce the risk of anastomotic leaks and other complications after surgery for ovarian cancer, compared with standard intra-operative assessments alone. The PINPOINT endoscopic fluorescence imaging system uses a special camera and a fluorescent (glowing) dye that can evaluate the blood flow of the bowel in real-time. If there is an area that appears concerning, the surgeon can correct the problem during the procedure.
Eligibility Criteria
Participant Inclusion Criteria
Part 1 (pre-operative):
Diagnosed with primary or recurrent ovarian, fallopian tube, or primary peritoneal cancer
Scheduled to undergo debulking or cytoreductive surgery
Suspected need for a low anterior rectosigmoid resection at the time of a debulking procedure
Enrolled and consented before the operation
Part 2 (intra-operative):
Completed rectosigmoid resection
Surgeon plans to perform colorectal anastomosis
Participant Exclusion Criteria
Part 1 (pre-operative):
Documented history of allergic reaction to ICG
Not approached for study enrollment before undergoing an unexpected low anterior rectosigmoid resection
Part 2 (intra-operative):
Did not undergo rectosigmoid resection intraoperatively
Surgical procedure with rectosigmoid resection for any other type of gynecologic malignancy
Patient requires permanent colostomy
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There are 7 Locations for this study
Basking Ridge New Jersey, 07920, United States More Info
Middletown New Jersey, 07748, United States More Info
Montvale New Jersey, 07645, United States More Info
Commack New York, 11725, United States More Info
Harrison New York, 10604, United States More Info
New York New York, 10065, United States More Info
Uniondale New York, 11553, United States More Info
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