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Registry for Patients Undergoing Pulmonary Procedures

This study has been terminated.
(funding/ enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01397292
First Posted: July 19, 2011
Last Update Posted: March 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Virginia Commonwealth University
  Purpose

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.


Condition
Pulmonary Procedures

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Registry Examining Retrospective and Prospective Data for Patients Undergoing Pulmonary Procedures

Further study details as provided by Virginia Commonwealth University:

Enrollment: 220
Study Start Date: July 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ONLY ADULT PATIENTS (>18 YEARS OLD) that have a planned PULMONARY PROCEDURE will be potential participants. This will also include a special group, prisoners.
Criteria

Inclusion Criteria:

  • ADULT PATIENTS (>18 YEARS OLD) that have a planned PULMONARY PROCEDURE

Exclusion Criteria:

  • ALL KNOWN PREGNANT PATIENTS WILL BE EXCLUDED FROM THIS REGISTRY.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01397292


Locations
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23060
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Hans J Lee, M.D. Virginia Commonwealth University
  More Information

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01397292     History of Changes
Other Study ID Numbers: HM13603
First Submitted: July 15, 2011
First Posted: July 19, 2011
Last Update Posted: March 19, 2013
Last Verified: July 2011

Keywords provided by Virginia Commonwealth University:
Bronchoscopy
Interventional Pulmonary
Pleuroscopy
Tracheostomy