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NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study

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. Identifier: NCT01394978
Recruitment Status : Completed
First Posted : July 15, 2011
Results First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Information provided by (Responsible Party):
C. R. Bard

Brief Summary:
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 or disease Intervention/treatment Phase
Lung Cancer Lung Tumor Other: Control Device: ProGEL Pleural Air Leak Sealant Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 444 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2011
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No treatment.
Other: Control
Standard surgical techniques including staples and sutures.

Experimental: 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).

Primary Outcome Measures :
  1. Safety Endpoints [ Time Frame: 90 days ]
    • 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 identifier (NCT number): NCT01394978

United States, Alabama
St. Vincent Birmingham & St. Vincent East
Birmingham, Alabama, United States, 35243
University of Alabama in Birmingham
Birmingham, Alabama, United States, 35894
United States, Florida
Jacksonville Center for Research
Jacksonville, Florida, United States, 32207
Moffit Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
WellStar Research Institute
Atlanta, Georgia, United States, 30060
Emory University
Atlanta, Georgia, United States, 30322
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
St. Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States, 46290
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
United States, Massachusetts
Mass General Hospital
Boston, Massachusetts, United States, 02114
Brigham Womens' Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deconess Medical Center
Boston, Massachusetts, United States, 02215
UMass Memorial Medical
Worcester, Massachusetts, United States, 01605
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Pennsylvania
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17602
United States, Virginia
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
United States, Wisconsin
Dean Foundation for Health, Research and Education, Inc.
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

Responsible Party: C. R. Bard Identifier: NCT01394978     History of Changes
Other Study ID Numbers: NEO09-100
First Posted: July 15, 2011    Key Record Dates
Results First Posted: July 11, 2017
Last Update Posted: July 11, 2017
Last Verified: June 2017

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