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A Pivotal Study to Evaluate the Safety and Effectiveness of RMT Medical Technology's SafeFlo® Vena Cava Filter

NCT00654979 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2013-05-31

No results posted yet for this study

Summary

To determine the safety and effectiveness of the SafeFlo filter for permanent protection against pulmonary emboli. All patients will be selected to receive the filter according to the stated inclusion / exclusion criteria after consultation between the attending physician and interventional radiologist. Patients with a permanent implantation will be followed for up to 6 months. Clinical success will be defined as no occurrences of any of the following events: recurrent pulmonary embolism, IVC occlusion or filter embolization. The proportion of permanent filter patients considered to be a clinical success will be the primary efficacy parameter.

Conditions

Interventions

DEVICE

SafeFlo IVC Filter

SafeFlo IVC Filter

Sponsors & Collaborators

  • RMT Medical Technologies, Ltd.

    lead INDUSTRY

Principal Investigators

  • Jacob Cynamon, Dr. · Montefiore Medical Center

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States
  • Austria
  • Greece
  • Israel
  • South Africa
  • United Kingdom

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 NCT00654979 on ClinicalTrials.gov