NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by C. R. Bard
Sponsor:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT01394978
First received: July 13, 2011
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

The purpose of this post approval study is to further characterize the safety profile of the ProGEL™ Pleural Air Leak Sealant in commercial use, with specific reference to long-term safety over 90 days of follow-up.


Condition Intervention Phase
Lung Resection
Open Thoracotomy
Other: Standard surgical techniques
Device: Standard surg. techniques plus ProGEL Pleural Air Leak Sealant
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: AirTight: A Prospective Controlled Post-Approval Study of NeoMend ProGEL™ Pleural Air Leak Sealant in the Treatment of Visible Pleural Air Leaks After Standard Pleural Closure

Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • Safety endpoints [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    • Pulmonary adverse events: pneumothorax, persistent air leak, late onset air leak, residual pleural space, and acute respiratory distress syndrome
    • Renal adverse events
    • Cardiac adverse events
    • Death (all causes)
    • Hospital readmission


Estimated Enrollment: 400
Study Start Date: June 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control Other: Standard surgical techniques
Surgical techniques including staples, and sutures.
ProGEL Pleural Air Leak Sealant Device: Standard surg. techniques plus ProGEL Pleural Air Leak Sealant
ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled for an open thoracotomy for lung resection
  • Has at least one or more intraoperative visible air leak >= 2 mm following the lung resection surgery

Exclusion Criteria:

  • Pregnant or breast feeding
  • History of an allergic reaction to Human Serum Albumin
  • Has a significant clinical disease or condition
  • Had previous open thoracotomy procedures
  • Unable to participate in all necessary study activities due to physical or mental limitations
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394978

Contacts
Contact: Alayne Lehman, RN, MS 949-783-3444 alayne.lehman@crbard.com

Locations
United States, Alabama
University of Alabama in Birmingham Recruiting
Birmingham, Alabama, United States, 35894
Contact: Ashlee Rawlins, BS    205-996-7561      
Principal Investigator: Robert J. Cerfolio, MD         
Sub-Investigator: Ayesha Bryant, MD         
St. Vincent Birmingham & St. Vincent East Recruiting
Birmingham, Alabama, United States
Contact: Kathryn Phillips, RN    205-716-6915      
Principal Investigator: John Richardson, MD         
United States, Florida
Moffit Cancer Center Recruiting
Tampa, Florida, United States, USA
Contact: Elise Perez    813-745-8956      
Principal Investigator: Eric Toloza, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Jennifer Noel Walker, RN, BSN    404-778-2198      
Principal Investigator: Daniel L. Miller, MD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States
Contact: Sally Coffman, RN    317-948-8818      
Principal Investigator: Kenneth Kesler, MD         
St. Vincent Hospital and Health Care Center Recruiting
Indianapolis, Indiana, United States
Contact: Lisa Barnett, RN, BSN    317-583-7804      
Principal Investigator: Richard Freeman, MD         
United States, Massachusetts
Mass General Hospital Recruiting
Boston, Massachusetts, United States
Contact: Diane Davies, BSN, RN    617-653-4390      
Principal Investigator: John Wain, MD         
Beth Israel Deconess Medical Center Recruiting
Boston, Massachusetts, United States
Contact: Aishatu Aloma, MBBS, MPH    617-632-8386      
Principal Investigator: Sidhu Gangadharan, MD         
UMass Memorial Medical Recruiting
Worcester, Massachusetts, United States
Contact: Heather Strom    508-856-1729      
Principal Investigator: Geoffrey Graeber, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States
Contact: Karlyn Pierson, RN    507-538-1960      
Principal Investigator: Robert Shen, MD         
United States, Wisconsin
Dean Foundation for Health, Research and Education, Inc. Recruiting
Madison, Wisconsin, United States
Contact: Marjorie Walrath, MSN, RN    608-260-2900      
Principal Investigator: John Snider, MD         
Sponsors and Collaborators
C. R. Bard
Investigators
Principal Investigator: Robert J. Cerfolio, MD University of Alabama in Birmingham
Principal Investigator: Daniel L. Miller, MD Emory University
  More Information

No publications provided

Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT01394978     History of Changes
Other Study ID Numbers: NEO09-100
Study First Received: July 13, 2011
Last Updated: September 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by C. R. Bard:
Pleural air leak
Pulmonary resection
Open thoracotomy

ClinicalTrials.gov processed this record on July 22, 2014