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Angel® Catheter Early Feasibility Clinical Study

NCT01847196 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2015-08-26

Study results available
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Summary

The primary objective of this clinical trial is to obtain initial insights into the safety of the Angel® Catheter in critically ill subjects with high risk of venous thromboembolism (VTE) disease AND who are not receiving pharmacological thromboprophylaxis.

Conditions

Interventions

DEVICE

Angel® Catheter

The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). The device is designed to be placed in the inferior vena cava, via the femoral vein, for the prevention of Pulmonary Embolism (PE), and for access to the central venous system. The device is intended for short-term use (less than 30 days) and must be removed before hospital discharge.

Sponsors & Collaborators

  • BiO2 Medical

    lead INDUSTRY

Principal Investigators

  • Martin Schreiber, MD · Oregon Health and Science University

  • Larry Martin, MD · University of Mississippi Medical Center

  • John Holcomb, MD · The University of Texas Health Science Center, Houston

  • Michael Cripps, MD · University of Texas Southwestern Medical Center (Dallas)

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-06-30
Completion
2014-06-30

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 NCT01847196 on ClinicalTrials.gov