Status:
COMPLETED
Diagnostic Value of ICG in Endometriosis
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Endometriosis
Laparoscopy
Eligibility:
FEMALE
18+ years
Phase:
EARLY_PHASE1
Brief 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.
Detailed Description
Endometriosis is a public health problem with an increasing incidence and various symptoms. Surgical treatment reliefs pain and improves fertility by radically removing endometriotic lesions. However,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT03850158
Start Date
January 1 2017
End Date
December 1 2019
Last Update
January 18 2020
Active Locations (1)
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1
Department of Obstetrics and Gynecology, University Hospital of Bern, Inselspital
Bern, Switzerland, 3010