NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study

This study is currently recruiting participants.
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
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 April 15, 2014