NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT01394978
First received: July 13, 2011
Last updated: March 14, 2016
Last verified: March 2016
  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
Lung Cancer
Lung Tumor
Other: Control
Device: ProGEL Pleural Air Leak Sealant

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


Enrollment: 444
Study Start Date: June 2011
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control
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).

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.
  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

Locations
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
St. Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States, 46290
Indiana University
Indianapolis, Indiana, United States, 46202
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
Investigators
Principal Investigator: Robert J. Cerfolio, MD University of Alabama in Birmingham
Principal Investigator: Daniel L. Miller, MD WellStar Research Institute
  More Information

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: March 14, 2016
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 27, 2016