Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2026-01-24 @ 2:34 PM
Study NCT ID:
NCT03332004
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2017-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Near-infrared Fluorescence Imaging as a Supportive Tool for Localisation of Deep Infiltrating Endometriosis During Laparoscopy
Sponsor:
Catholic University of the Sacred Heart
Organization:
Study Overview
Official Title:
Indocyanine Green and Near-Infrared Vision for Detection of Endometriosis (GRE-Endo Trial)
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: