NCT02547909|WithdrawnDMC
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Sponsor study identifier
interventional
0
1 country
1
Study Start
May 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 31, 2015
Actual (reported)September 11, 2015
Actual (reported)May 2016
Date type not reportedThis date has not been verified as actual or estimated.
October 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
recognizing unique pCLE images for endometriosis
intraoperative
a probe-based Confocal Laser Endomicroscopy examination will be done using a standard recto-sigmoidoscopy, in women suffering from endometriosis who are referred for a TRUS examination as part of a suspected deep endometriosis diagnostic workup. pCLE images will be compared to normal bowel mucosa.
Eligible women will be offered to undergo pCLE examination. Conscious sedation will be offered to all patients, who will choose to receive it or not. pCLE will be done using a standard gastroscope, reaching a distance of 25 cm from the anus, to the level of the rectosigmoid angle. At this point, 2.5 ml fluorescein 10% will be injected. The pCLE probe (GastroFlex-UHD probe, Mauna Kea tech, Paris, France) will be inserted through the endoscope working channel and images will be recorded from areas suspected of harboring an endometriotic tissue.
Sheba Medical Center
Ramat Gan, 52621, Israel
Ofir Har-Noy, MD
Sheba Medical Center
0 participants (actual enrollment reported by the registry).
First Submitted
August 31, 2015
First Posted
September 11, 2015
Study Start
May 2016
Date type not reportedThis date has not been verified as actual or estimated.
Validation of Clinical Efficacy and Development of New Diagnostic Algorithm of Probe-based Confocal Laser Endomicroscopy in Patients With Lower Gastrointestinal Disorder
Contact the study team to confirm eligibility.
Primary Completion
October 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 24, 2017
Record last verified: 2017-10
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Source: ClinicalTrials.gov.
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