A Study of Intra-operative Imaging in Women With Ovarian Cancer

RECRUITING

I'm interested ...!!

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.

Conditions:

🦠 Ovarian Cancer 🦠 Ovarian Carcinoma

🗓️ Study Start (Actual) 3 May 2021

🗓️ Primary Completion (Estimated) 3 May 2025

✅ Study Completion (Estimated) 3 May 2025

👥 Enrollment (Estimated) 310

🔬 Study Type INTERVENTIONAL

📊 Phase PHASE3

Locations:

📍 Basking Ridge, New Jersey, United States

📍 Middletown, New Jersey, United States

📍 Montvale, New Jersey, United States

📍 Commack, New York, United States

📍 Harrison, New York, United States

📍 New York, New York, United States

📍 Uniondale, New York, United States

📍 Willow Grove, Pennsylvania, United States

More locations available...

📋 Eligibility Criteria

Description

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

Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)

Sexes Eligible for Study: FEMALE

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 4 May 2021
First Submitted that Met QC Criteria 4 May 2021
First Posted 7 May 2021

Study Record Updates