NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by C. R. Bard
Information provided by (Responsible Party):
C. R. Bard Identifier:
First received: July 13, 2011
Last updated: February 3, 2015
Last verified: February 2015
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 Cancer
Lung Tumor
Other: Standard surgical techniques
Device: 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

Resource links provided by NLM:

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
Standard surgical technique including staples and sutures.
Other: Standard surgical techniques
Standard surgical techniques including staples and sutures.
ProGEL Pleural Air Leak Sealant
Standard surgical technique plus Progel Pleural Air Leak Sealant.
Device: 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).

Detailed Description:
Patients having open thoracotomy involving lung resection surgery will be considered for the study. Subjects will be examined for adverse events and complications from either the treatment or the procedure. Follow-up visits are required at 30 days and 90 days after the surgery.

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

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 identifier: NCT01394978

Contact: Alayne Lehman, RN, MS 949-783-3444

United States, Alabama
St. Vincent Birmingham & St. Vincent East Active, not recruiting
Birmingham, Alabama, United States, 35243
University of Alabama in Birmingham Recruiting
Birmingham, Alabama, United States, 35894
Contact: Sandra Calloway, BS    205-975-4437      
Principal Investigator: Robert J. Cerfolio, MD         
Sub-Investigator: Ayesha Bryant, MD         
United States, Florida
Jacksonville Center for Research Recruiting
Jacksonville, Florida, United States, 32207
Contact: Tajonda Bradley    904-861-3050      
Principal Investigator: Robert Still, MD         
Moffit Cancer Center Completed
Tampa, Florida, United States, 33612
United States, Georgia
WellStar Research Institute Recruiting
Atlanta, Georgia, United States, 30060
Contact: Pamela Yaun, RN    678-331-6848      
Principal Investigator: Daniel Miller, MD         
Emory University Completed
Atlanta, Georgia, United States, 30322
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Xin Zhong, RN    317-274-5495      
Principal Investigator: Kenneth Kesler, MD         
St. Vincent Hospital and Health Care Center Recruiting
Indianapolis, Indiana, United States, 46290
Contact: Lisa Barnett, RN, BSN    317-583-7804      
Principal Investigator: Richard Freeman, MD         
United States, Maryland
Greater Baltimore Medical Center Recruiting
Baltimore, Maryland, United States, 21204
Contact: Troy Gogoll    443-849-3592      
Principal Investigator: Neri Cohen, MD         
United States, Massachusetts
Mass General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Diane Davies, BSN, RN    617-653-4390      
Principal Investigator: John Wain, MD         
Brigham Womens' Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Sarah Rogers    617-525-8541      
Principal Investigator: Jon Wee, MD         
Beth Israel Deconess Medical Center Completed
Boston, Massachusetts, United States, 02215
UMass Memorial Medical Recruiting
Worcester, Massachusetts, United States, 01605
Contact: Heather Strom    508-856-1729      
Principal Investigator: Geoffrey Graeber, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Karlyn Pierson, RN    507-538-1960      
Principal Investigator: Robert Shen, MD         
United States, Pennsylvania
Lancaster General Hospital Recruiting
Lancaster, Pennsylvania, United States, 17602
Contact: Deborah Ramsey, RN    717-544-1777      
Principal Investigator: Jennifer Worth, MD         
United States, Virginia
Virginia Commonwealth University Medical Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Stella Hamman, RN    804-628-2520      
Principal Investigator: Anthony Cassano, MD         
United States, Washington
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98104
Contact: Tina Brennan    206-386-2450      
Principal Investigator: Eric Vallieres, MD         
United States, Wisconsin
Dean Foundation for Health, Research and Education, Inc. Completed
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
C. R. Bard
Principal Investigator: Robert J. Cerfolio, MD University of Alabama in Birmingham
Principal Investigator: Daniel L. Miller, MD WellStar Research Institute
  More Information

No publications provided

Responsible Party: C. R. Bard Identifier: NCT01394978     History of Changes
Other Study ID Numbers: NEO09-100 
Study First Received: July 13, 2011
Last Updated: February 3, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by C. R. Bard:
Pleural air leak
Pulmonary resection
Open thoracotomy processed this record on February 11, 2016