Status:
COMPLETED
Near-infrared Fluorescence Imaging as a Supportive Tool for Localisation of Deep Infiltrating Endometriosis During Laparoscopy
Lead Sponsor:
Catholic University of the Sacred Heart
Conditions:
Pelvic Endometriosis
Endometriosis Outside Pelvis
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
Brief Summary
The aim of the study is to establish a new and more accurate method to visualize the peritoneal changes caused by endometriosis using Indocyanine Green mediated fluorescence imaging. The hypothesis is...
Detailed Description
Patients were recruited within the clinical routine after indication for laparoscopy under consideration of the inclusion and exclusion criteria. The first abdominal and pelvi's inspection was made u...
Eligibility Criteria
Inclusion
- Suspected endometriosis with necessity for laparoscopic confirmation and resection
- Regular menstrual cycles
Exclusion
- Patients younger than 18 years and older than 50 years at time of operation
- Subject with previous history of adverse reaction or allergy to Indocyanine Green, iodine, shellfish or iodine dyes
- Documented allergy to sulfur containing compounds
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Indocyanine Green
- Subject has significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests (Total bilirubin increased by factor 1.5 than normal and/or serum glutamic oxaloacetic transaminase increased by factor 2 than normal)
- Subject has uremia, serum creatinine (\> 2.0 mg/dl)
- Subject has severe coronary heart disease (instable angina pectoris)
- Pregnant or breast-feeding women
- Subject actively participating in another drug, biologic and/or device protocol
- The presence of medical conditions contraindicating general anesthesia or standard surgical approaches
- Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
Key Trial Info
Start Date :
January 4 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2017
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03332004
Start Date
January 4 2016
End Date
February 16 2017
Last Update
November 6 2017
Active Locations (1)
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1
Catholic University of Sacred Heart
Rome, Italy, 00168