Ignite Creation Date:
2024-05-06 @ 1:24 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04012476
Status:
UNKNOWN
Last Update Posted:
2019-07-09
First Post:
2019-06-28
Brief Title:
Determination of Parathyroid Function by Fluorescence With Indocyanine Green ICG After Total Thyroidectomy
Sponsor:
Hospital Son Espases
Organization:
Hospital Son Espases
Study Overview
Official Title:
Determination of Parathyroid Function by Fluorescence With Indocyanine Green ICG After Total Thyroidectomy
Status:
UNKNOWN
Status Verified Date:
2019-07
Last Known Status:
RECRUITING
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 intensity of parathyroid fluorescence that occurs after intravenous injection of indocyanine green during the performance of a total thyroidectomy correlates with postoperative parathyroid function and could be used as a diagnostic marker of postoperative hypoparathyroidism and hypocalcemia
Detailed Description:
The main objective of the study is to compare the intensity of parathyroid fluorescence among patients who present post-thyroidectomy hypocalcemia with that of patients who do not have it Therefore the following points will be studied
To study the correlation between parathyroid vascularization intraoperative fluorescence intensity and postoperative glandular function serum calcium and parathormone levels
To compare the surgeons subjective assessment of parathyroid fluorescence in the groups of patients with and without postoperative hypocalcemia
To compare the objective assessment of parathyroid fluorescence by using specific computer software developed ad hoc in the groups of patients with and without postoperative hypocalcemia
To study the correlation between parathyroid vascularization intraoperative fluorescence intensity and postoperative glandular function serum calcium and parathormone levels
To compare the surgeons subjective assessment of parathyroid fluorescence in the groups of patients with and without postoperative hypocalcemia
To compare the objective assessment of parathyroid fluorescence by using specific computer software developed ad hoc in the groups of patients with and without postoperative hypocalcemia
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