drugset / Trial / NCT02547909

The Application of Probe-based Confocal Laser Endomicroscopy in the Diagnosis of Deep Endometriosis

NCT02547909

Withdrawn Dr. Ofir Harnoy MD
NaSingle-groupOpen-labelDiagnostic

Summary

Endometriosis is defined as the presence of endometrial glands and stroma outside of the uterus.Endometriosis affects 5%-15% of women in the reproductive age. Deep endometriosis is mostly defined as a single endometrial nodule, located in the vesico-uterine fold or close to the distal 20 cm of the large bowel. Current guidelines recommends that laparoscopy with histology should be done to diagnose endometriosis. Probe-based confocal laser endomicroscopy (pCLE) has been used as a GI tract endoscopy additive tool in recent years, providing in-vivo cellular-level imaging, a concept known as "optical biopsy". considering the rectal bleeding that occurs in patients suffering from bowel endometriosis, usually with a normal mucosa seen at standard endoscopy (personal data), we hypothesized that there might be histological architectural changes in the vessels or the mucosa/sub mucosa in bowel endometriosis.

Timeline

Start
2016-05
Primary completion
2017-10
Completion
2017-10

Drugs

EvaluationDrugModalityDoseRoute
Background Fluorescein Diagnostic / imaging agent 2.5 ml