Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-28 @ 9:19 PM
Study NCT ID:
NCT06129669
Status:
UNKNOWN
Last Update Posted:
2023-11-13
First Post:
2023-10-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ICG Indocyanine Green in Reconstructive Surgery
Sponsor:
Amsterdam UMC, location VUmc
Organization:
Study Overview
Official Title:
Determining Critical Thresholds of Tissue Perfusion With ICG in Reconstructive Surgery
Status:
UNKNOWN
Status Verified Date:
2023-11
Last Known Status:
ENROLLING_BY_INVITATION
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:
ICG-R
Brief Summary:
The success or failure of a reconstruction is largely related to the vascularization of the operated area. Near infrared fluorescence (also near infrared fluorescence angiography, NIR FA) with ICG administration is an innovative technique to quantify tissue perfusion. Based on the results obtained in other subspecialties, NIR fluorescence appears to be a promising way to quantify tissue perfusion in reconstructive surgery. Fluorescence research has previously been used in the context of microsurgery and breast reconstructions using implants, but structural objective determinations are lacking. Our study is successful if we are able to determine a cut off value for the absolute or relative perfusion parameters.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
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?: