Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2025-12-24 @ 8:00 PM
NCT ID:
NCT03332004
Eligibility Criteria:
Inclusion Criteria:
* Suspected endometriosis with necessity for laparoscopic confirmation and resection
* Regular menstrual cycles
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03332004
Study Brief:
Protocol Section:
NCT03332004