NCT02038985

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

An Evaluation of Fluorescence Imaging + ICG Dye (Firefly) for Use in the Visual Diagnosis of Endometriosis: A Prospective Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: AdventHealth · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Endometriosis

Interventions

Type	Name	Description
OTHER	Participants will receive ICG Dye	Participants will receive ICG Dye preoperatively for use in the Visual Diagnosis of Endometriosis

Timeline

• Start date: 2013-06-01
• Primary completion: 2016-07-01
• Completion: 2016-08-16
• First posted: 2014-01-17
• Last updated: 2017-10-06

Locations

1 site across 1 country: United States