Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421103
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-01-08
Brief Title:
Micro-dosing Indocyanine Green ICG in Children
Sponsor:
Great Ormond Street Hospital for Children NHS Foundation Trust
Organization:
Great Ormond Street Hospital for Children NHS Foundation Trust
Study Overview
Official Title:
Investigating Micro-dosing of Indocyanine Green ICG for Intraoperative Perfusion Assessment in Children
Status:
RECRUITING
Status Verified Date:
2024-05
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 goal of this cohort study is to identify the lowest dose of Indocyanine Green ICG that achieves satisfactory intra-operative fluorescence for the assessment of gastrointestinal or genitourinary tract perfusion in children
Detailed Description:
Indocyanine Green ICG fluorescence-guided surgery FGS can be used to assess gastrointestinal and genitourinary tract perfusion intra-operatively In adults the use of ICG has been shown to improve surgical outcomes ICG is safely used intra-operatively in children but there is a lack of evidence regarding the lowest clinically useful dose of ICG
This is a single centre open-label dose escalation study that aims to
1 identify the minimal clinically useful dose of ICG for intra-operative perfusion assessment in children 0 - 18 years old
2 assess the safety profile of intra-operative ICG in children
3 characterise the intra-operative fluorescence of ICG in children
This is a single centre open-label dose escalation study that aims to
1 identify the minimal clinically useful dose of ICG for intra-operative perfusion assessment in children 0 - 18 years old
2 assess the safety profile of intra-operative ICG in children
3 characterise the intra-operative fluorescence of ICG in children
Study Oversight
Has Oversight DMC:
None
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?:
None