Viewing Study NCT01397292


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Study NCT ID: NCT01397292
Status: TERMINATED
Last Update Posted: 2013-03-19
First Post: 2011-07-15
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Registry for Patients Undergoing Pulmonary Procedures
Sponsor: Virginia Commonwealth University
Organization:

Study Overview

Official Title: Registry Examining Retrospective and Prospective Data for Patients Undergoing Pulmonary Procedures
Status: TERMINATED
Status Verified Date: 2011-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: funding/ enrollment
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this research study is to examine the safety, tolerability, and effectiveness of currently available pulmonary procedures when used to diagnose or treat different diseases.

This study will collect information that may influence the outcome of the procedure and identify factors that may affect the procedures yield or safety. The information will be entered into a registry or data storage.
Detailed Description: This is a retrospective and prospective data registry of all pulmonary diagnostic and therapeutic interventional pulmonary procedures at a single academic center. All pulmonary procedures upon completion will be entered into a database by the participating investigator performing the procedure. For both diagnostic and therapeutic cases, the data will require additional input 1-4 weeks after the procedure in order to place the diagnosis and follow-up data. Retrospective data will only be collected for patients that had their procedures prior to approval of this registry.

Study data will be collected and managed using REDCap (Research Electronic Data Capture) electronic data (CTSA Awared - Award Number UL1RR031990) capture tools hosted at Virginia Commonwealth University. REDCap is a secure, web-based application designed to support data capture for research studies.

The prison population will also be included in the registry in order to examine the effects of pulmonary procedures on a special population.

Study Oversight

Has Oversight DMC: False
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?: