Viewing Study NCT03850158


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Study NCT ID: NCT03850158
Status: COMPLETED
Last Update Posted: 2020-01-18
First Post: 2019-02-19
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Diagnostic Value of ICG in Endometriosis
Sponsor: Insel Gruppe AG, University Hospital Bern
Organization:

Study Overview

Official Title: Visualization of Peritoneal Endometriosis With 2D-Laparoscopy and Indocyanine Green
Status: COMPLETED
Status Verified Date: 2020-01
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: This study evaluates the diagnostic value of the addition of indocyanine green and near infrared fluorescence imaging during laparoscopy in patients with suspected endometriosis.
Detailed Description: Endometriosis is a public health problem with an increasing incidence and various symptoms. Surgical treatment reliefs pain and improves fertility by radically removing endometriotic lesions. However, peritoneal endometriotic lesions may vary significantly in their appearance in standard white light laparoscopy and therefore may be difficult to be identified. Because endometriosis is associated with hypervascularisation the visualization of tissue perfusion by additional use of near infrared (NIR) fluorescence imaging with indocyanine green (ICG) may improve the detection of peritoneal endometriotic lesions.

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?: True
Is an FDA AA801 Violation?: