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

Fluorescence imaging has been used for visualization of tissue perfusion in colorectal
surgery, detection of pathologic primary and metastatic tumors, and measurement of graft
patency in cardiovascular surgery. The da Vinci® Firefly Imaging System, through the use of
fluorescence imaging, allows surgeons to view high-resolution near infrared images of blood
flow and tissue perfusion in real-time during robotic-assisted surgical procedures, such as
during a robotic-assisted endometriosis resection.

Using standard white light imaging, endometriotic lesions can appear red and vascular, white
and scarred, black, brown, yellow, or almost any color; atypical implants are clear and can
seem like normal tissue. However, there are some published reports demonstrating that the
lesions of endometriosis are hypervascular and may be visualized radiographically on the
basis of this pathologic feature. Because the individual lesions of endometriosis can vary
significantly in their appearance under standard white light, using the hypervascular
characteristic of this disease along with the Firefly technology may provide consistency in
intraoperative visual diagnosis, and thus may aid the detection and resection of
endometriosis.

The ability to accurately visualize all the lesions of endometriosis, typical and atypical in
appearance, and thus facilitate complete resection of the disease, may have a significant
impact on symptomatic relief and disease recurrence. The Firefly Imaging System of
fluorescence imaging + ICG dye may allow for more accurate visual diagnosis of endometriosis
during a robotic-assisted endometriosis resection procedure, and therefore may have a
positive impact for patients with this disease.

This is a prospective, comparison, single-center, observational study to evaluate
fluorescence imaging + ICG dye (Firefly), compared to standard white light imaging in 2D and
3D, for accurate visual diagnosis of endometriosis during a da Vinci endometriosis resection
procedure.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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