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

NCT02038985 | Terminated

• 1 other identifier: 451140
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometriosis

Keywords

Endometriosis; Robotic Surgery; Diagnostic Imaging

Outcome Measures

Primary Outcomes (1)

• Quality of fluorescence imaging using + ICG dye (Firefly).

  Quality is defined by the investigators perception of accuracy of visual diagnosis and how clear are the the resultant images used for visualization and mapping of lesions. The quality of the fluorescence imaging + ICG dye (Firefly) will be compared to standard white light imaging in 2D and 3D for accurate visual diagnosis of endometriosis during a da Vinci endometriosis resection procedure

  1 hour

Secondary Outcomes (1)

• Quality of Life

  3 months

Study Arms (1)

+ ICG Dye (Firefly)

OTHER

Participants will receive ICG Dye

Other: Participants will receive ICG Dye

Interventions

Participants will receive ICG Dye OTHER

Participants will receive ICG Dye preoperatively for use in the Visual Diagnosis of Endometriosis

+ ICG Dye (Firefly)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

Florida Hospital Celebration Health

Celebration, Florida, 34747, United States

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Aileen Caceres, MD

  Florida Hospital Celebration Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2013
• First Posted: January 17, 2014
• Study Start: June 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: August 16, 2016
• Last Updated: October 6, 2017

Record last verified: 2017-10

Locations

US (1)