Viewing Study NCT02240251


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Study NCT ID: NCT02240251
Status: COMPLETED
Last Update Posted: 2023-05-12
First Post: 2014-09-10
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Excimer Laser Assisted IVC Filter Retrieval
Sponsor: Northwestern University
Organization:

Study Overview

Official Title: A Prospective Review of Excimer Laser Assisted Inferior Vena Cava (IVC) Filter Retrieval
Status: COMPLETED
Status Verified Date: 2023-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This is a prospective chart review to follow our laser-assisted IVC filter retrieval patients. We intend to validate existing literature and scientific findings by publishing our own clinical experience in difficult IVC filter retrievals.
Detailed Description: At Northwestern Memorial Hospital in Chicago, IL USA, IVC filters are successfully removed \>95%. Technical failures, although rare, are usually related to excessive endoluminal scarring at the point of IVC filter implantation. Adjunctive (or advanced) removal techniques are often employed in difficult cases. The excimer laser sheath has been successfully used at Northwestern for patients who had failed all other retrieval techniques.

Before a patient is to undergo an IVC filter removal using the Excimer Laser Sheath they will be consented to participate in the chart review study and become a part of a registry kept at Northwestern Memorial Hospital. The procedure itself is not being used as part of the study. Chart reviews will be completed and data collected on the procedure to remove the filter. Follow up after the procedure by phone call and chart review will be completed at least once, 1 week after the filter removal.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: