Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2025-12-24 @ 3:03 PM
Study NCT ID:
NCT06868459
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-08
First Post:
2025-03-05
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pressure-enabled Retrograde Occlusive Therapy With Embolization for Control of Thyroid Disease (PROTECT Registry): A Multicenter Registry
Sponsor:
Sarasota Memorial Health Care System
Organization:
Study Overview
Official Title:
Pressure-enabled Retrograde Occlusive Therapy With Embolization for Control of Thyroid Disease (PROTECT Registry): A Multicenter Registry
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-03
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:
Multi-center registry study to evaluate disease-related quality of life outcomes of thyroid embolization via pressure-enabled delivery (PED-TAE). Additional technical success data on parenchymal volume reduction, thyroid function tests changes and post-procedural complications will be recorded. Data will be collected for patients who have undergone PED-TAE using the TriNav Infusion System at participating sites. The registry study will include up to 10 sites, with Sarasota Memorial Health Care System acting as the lead site responsible for maintaining and monitoring the study database.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: