Fluorescence Imaging + ICG Dye for Use in the Visual Diagnosis of Endometriosis

Stopped early · Not applicable

Conditions studied: Endometriosis

In brief

The purpose of this study is to evaluate the use of fluorescence imaging + Indocyanine Green (ICG) dye ("Firefly"), compared to standard white light imaging in 2D and 3D, for accurate visual diagnosis of endometriosis during a da Vinci robotically guided endometriosis resection procedure.

Key facts

Study ID

NCT02038985

Run by

AdventHealth

People needed

18

Starts

2013-06-01

Expected to finish

2016-08-16

Last updated by the study team

2017-10-06

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Be premenopausal (menopause is defined as amenorrhea lasting one year or longer)
• Have symptoms consistent with endometriosis, including the presence of one or more of the following: dysmenorrhea; dyspareunia; chronic pelvic pain (>6 months duration); pressure on the bladder or rectum causing difficult or painful bowel movements; infertility.
• Be willing to undergo planned da Vinci Endometriosis Resection Procedure

You may not qualify if…

• Known or suspected allergy to iodine, shellfish, or ICG dye
• Presence of medical conditions contraindicating general anesthesia or standard laparoscopic/ robotic surgery
• Active pelvic infection
• Previous history of radiation therapy to the pelvis
• Known or suspected pregnancy
• Presence of anatomy unsuitable for laparoscopic surgery
• Previously undiagnosed intra-abdominal or pelvic malignancy
• Inability of patient to tolerate Trendelenberg position or pneumoperitoneum

Where it is running

• Florida Hospital Celebration Health — Celebration, Florida, United States

Full record on ClinicalTrials.gov

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