Evaluating Outcomes in the Placement of Boomerang Percuta... | NCT00732628

Studies
Evaluating Outcomes in the Placement of Boomerang Percutaneous Device

NCT00732628

Sponsor

University of Michigan

Status

Terminated

Last Update Posted

Feb 24, 2009Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Medical Device
Angiography

Interventions

Boomerang closure device

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Physician is no longer associated with the Univ. of Michigan Medical Center

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Not provided

Completion Date

Sep 2008Actual

First Submitted Date

Jul 25, 2008

First Submission Date that Met QC Criteria

Aug 7, 2008

First Posted Date

Aug 12, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2009

Last Update Posted Date

Feb 24, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Boomerang percutaneous closure unit		patients having a Boomerang percutaneous closure device after a Neurointerventional study	Device: Boomerang closure device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Boomerang closure device	Device	Use of percutaneous of Boomerang closure device. Follow up outcomes evaluated after the use of Boomerang closure device.	Boomerang percutaneous closure unit

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any patient that has a percutaneous Boomerang closure device placed after having a neuro-intervention

Exclusion Criteria:

Patients that do not have this medical device used post procedure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients having a neurointerventional procedure, such as a cerebral angiography

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Michigan		Ann Arbor	Michigan	48109	United States