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Evaluating Outcomes in the Placement of Boomerang Percutaneous Device

2014-08-27 03:28:26 | BioPortfolio

Summary

The purpose of this study is to evaluate the safety and effectiveness of the Boomerang percutaneous closure device following diagnostic cerebral angiography or neurointerventional procedures.

Background:

Very few publications have evaluated this relatively novel percutaneous closure device.

Description

The purpose of this study is to document our experiences using the Boomerang closure device. Several different closure devices are used in the department of Radiology. A closure device is something that is placed in the artery in the leg just prior to removing the catheters from your leg at the end of the imaging or treatment procedure that is to be performed in the Department of Radiology. The devices used are all FDA approved. This study will compare the Boomerang device (a newer FDA approved device) to the other older devices currently being used. You may not have the Boomerang device used in your procedure; however, the Boomerang device is used in almost all of our patients undergoing a neuro imaging or treatment procedure. The neuroradiologist will determine which device if any is best for you based on the size of your artery, your medical condition etc. We will only collect data about you and your procedure if the Boomerang device is used.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Conditions

Medical Device

Intervention

Boomerang closure device

Location

University of Michigan
Ann Arbor
Michigan
United States
48109

Status

Terminated

Source

University of Michigan

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:28:26-0400

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Medical and Biotech [MESH] Definitions

Removal of a MEDICAL DEVICE from the market due to the identification of an intrinsic property of the device that results in a serious risk to public health.

Removal of a MEDICAL DEVICE from the market due to a problem occurring in the manufacture or distribution of the product.

Device designed to wear externally to support muscular skeletal system in various movements such as RANGE OF MOTIONS; WEIGHT-BEARING; GAIT; and LOCOMOTION.

The shifting in position or location of an INTRAUTERINE DEVICE from its original placement.

Removal of an implanted therapeutic or prosthetic device.

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