Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-01-01 @ 10:22 AM
Study NCT ID:
NCT06204159
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-20
First Post:
2024-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lipiodol Deposition Using Endhole vs. Pressure-Modulated Delivery
Sponsor:
Abramson Cancer Center at Penn Medicine
Organization:
Study Overview
Official Title:
Lipiodol Deposition in Hypervascular Tumors: Endhole vs. Pressure-modulated Delivery
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-05
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:
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:
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 853163 | OTHER | University of Pennsylvania IRB | View |