Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06204159
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2024-01-03
Brief Title:
Lipiodol Deposition Using Endhole vs Pressure-Modulated Delivery
Sponsor:
Abramson Cancer Center at Penn Medicine
Organization:
Abramson Cancer Center at Penn Medicine
Study Overview
Official Title:
Lipiodol Deposition in Hypervascular Tumors Endhole vs Pressure-modulated Delivery
Status:
RECRUITING
Status Verified Date:
2024-03
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:
Trinav
Brief Summary:
The goal of this clinical trial is to compare CT scan of the coverage of tumors treated with TACE using End Hole catheters to those treated with the TriNav catheter that alters tissue pressure Both catheters are FDA approved for delivery of TACE
Is there a difference in CT appearance with delivery in the type of catheter used during the TACE procedure
Participants will be asked to undergo a TACE procedure a CT scan and review of their medical record to compare End Hole and TriNav catheters during TACE procedures
Is there a difference in CT appearance with delivery in the type of catheter used during the TACE procedure
Participants will be asked to undergo a TACE procedure a CT scan and review of their medical record to compare End Hole and TriNav catheters during TACE procedures
Detailed Description:
Hepatocellular HCC and neuroendocrine NET liver metastases undergoing Lipiodol transarterial chemoembolization TACE will be randomized to endhole vs pressure-modulated catheter delivery Lipiodol deposition will be quantified and correlated with volumetric necrosis response and local progression
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 853163 | OTHER | University of Pennsylvania IRB | None |