Endometriosis Outside Pelvis Clinical Trial
Official title:
Indocyanine Green and Near-Infrared Vision for Detection of Endometriosis (GRE-Endo Trial)
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 that Indocyanine Green, a fluorescent dye that has wide applications throughout medicine in identifying vascularity of tissues and neovascularization, could facilitate the localization and excision of endometriotic lesions exploiting the hypervascularization due to the chronic inflammation
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 using direct laparoscope visualization
under white light conditions. All areas suspected of peritoneal endometriosis were classified
as white, black and red lesions and recorded together with their anatomic location in the
surgical record for the purposes of subsequent extirpation.
After the first visual inspection the patient was administered with 0.05 - 0.25 mg /(kg BW)
Indocyanine Green intravenously. The Indocyanine Green imaging mode of the Olympus
Indocyanine Green Imaging System was activated and suspected areas in Indocyanine Green
imaging mode were recorded with their corresponding appearance in white light mode.
If suspected areas were visible either in white light or Indocyanine Green imaging mode,
specific sample has been taken from these areas.
In addition control biopsy specimens from inconspicuous peritoneum has been taken.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03935165 -
Prospective Evaluation of Near-infrared Fluorescence Imaging Use as a Supportive Tool in Deep Infiltrating Endometriosis Surgery
|
Phase 2 | |
| Active, not recruiting |
NCT01838122 -
Prevalence of HbA1C in Women With PCOS
|
N/A |