Trials / Withdrawn
WithdrawnNCT03345225
A Clinical Study of Precision TACE (P-TACE) With Surefire
A Randomized Clinical Study of Precision TACE (P-TACE) With Surefire Infusion Catheter Versus Standard Endhole Catheter (E-TACE) Utilizing Radiopaque Drug Eluting Beads (LUMI) in Patients With Hepatocellular Carcinoma (HCC)
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- University of Miami · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this research study is to learn about 2 types of FDA-approved catheters used in angiographic (X-ray of blood vessels, with radiopaque substance) procedures like DEB-TACE treatment. The Principal Investigator will check the beads given during the DEB-TACE. They will compare the way in which they are spread out in the tumor and density (how condensed something is).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SureFire Infusion System | Surefire is a modified microcatheter with an expandable cone at its tip to prevent retrograde reflux of flow and change flow dynamics downstream. |
| DEVICE | Standard Endhole Microcatheter | A Microcatheter with a single hole at the end for a infusion. |
Timeline
- Start date
- 2018-05-01
- Primary completion
- 2021-05-01
- Completion
- 2021-11-01
- First posted
- 2017-11-17
- Last updated
- 2018-09-11
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03345225. Inclusion in this directory is not an endorsement.