Surefire Catheter Versus Standard End-hole Microcatheter: A Pilot Study

NCT02446925 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-07-28

No results posted yet for this study

Summary

The Surefire Infusion System is a novel catheter initially developed to prevent reflux of embolic material into non-target vascular territories. Further research has demonstrated improved penetration and distribution of embolic material into treated arterial territories. The purpose of this study is to compare Y-90 glass microsphere distribution and penetration into cancerous tissue within the liver between a standard endhole catheter and the Surefire Infusion System.

Conditions

Interventions

DEVICE

Surefire® Infusion System

Utilization of Surefire® Infusion System for Y-90 glass microsphere embolization

DEVICE

Standard End-hole catheter

Utilization of Standard End-hole catheter for Y-90 glass microsphere embolization

Sponsors & Collaborators

  • Surefire Medical, Inc.

    collaborator INDUSTRY
  • Wright State University

    lead OTHER

Principal Investigators

  • Shannon Kauffman, MD · Wright State University Boonshoft School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-01
Primary Completion
2018-12-19
Completion
2018-12-19

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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 NCT02446925 on ClinicalTrials.gov