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

NCT04878094 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2026-05-20

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Intravenous Indocyanine Green/ICG injection

Intravenous Indocyanine Green/ICG injection will be administered for visualization

DIAGNOSTIC_TEST

PINPOINT endoscopic fluorescence imaging system

After resection the surgeon will use the PINPOINT imaging system to assess perfusion of the colonic stump. The intervention will again be used following establishment of the anastomosis, however this time via a proctoscope to visualize the proximal and distal ends of the rectosigmoid anastomosis.

DIAGNOSTIC_TEST

Endoscopy

Standard technique and assessment of anastomosis without the use of NIR angiography

Sponsors & Collaborators

Principal Investigators

  • Mario Leitao, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-03
Primary Completion
2027-05-03
Completion
2027-05-03
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04878094 on ClinicalTrials.gov