Overview

Diagnostic Value of ICG in Endometriosis

Status:
Completed
Trial end date:
2019-12-01
Target enrollment:
0
Participant gender:
Female
Summary
This study evaluates the diagnostic value of the addition of indocyanine green and near infrared fluorescence imaging during laparoscopy in patients with suspected endometriosis.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital Inselspital, Berne
Criteria
Inclusion Criteria:

- Informed Consent as documented by signature

- Be premenopausal (menopause is defined as amenorrhea lasting one year or longer)

- Patients should be in follicular phase

- Have chronic pelvic pain and/or Infertility and be willing to undergo planned
endometriosis resection procedure.

Exclusion Criteria:

- Known or suspected allergy to iodine, shellfish, or ICG dye

- Hyperthyroidism

- Severe renal insufficiency

- Simultaneous therapy with beta-blockers

- Women who are pregnant (positive HCG in the blood) or breast feeding

- Intention to become pregnant during the course of the study

- Inability to follow the procedures of the study (due to language problems,
psychological disorders, dementia)

- Active pelvic infection (positive vaginal or cervical smears for bacteria or elevated
markers of infection in the blood)

- Previous history of radiation therapy of the pelvis

- Presence of medical conditions contraindicating general anesthesia or standard
laparoscopic surgery