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A Clinical Study of Precision TACE (P-TACE) With Surefire

NCT03345225 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-09-11

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Surefire Medical, Inc.

    collaborator INDUSTRY

  • University of Miami

    lead OTHER

Principal Investigators

  • Shree Venkat, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-31
Primary Completion
2021-05-31
Completion
2021-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03345225 on ClinicalTrials.gov