NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study
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
1 other identifier
interventional
444
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable lung-cancer
Started Jun 2011
Longer than P75 for not_applicable lung-cancer
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 13, 2011
CompletedFirst Posted
Study publicly available on registry
July 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedResults Posted
Study results publicly available
July 11, 2017
CompletedJuly 15, 2021
July 1, 2021
4.7 years
July 13, 2011
April 17, 2017
July 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety Endpoints
* 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
90 days
Study Arms (3)
Control
OTHERNo treatment.
ProGEL Pleural Air Leak Sealant with standard surgical closure
EXPERIMENTALStandard surgical closure (suturing or stapling of visible air leaks incurred during resection of lung parenchyma) plus Progel Pleural Air Leak Sealant.
ProGEL Pleural Air Leak Sealant without standard surgical closure
EXPERIMENTALProgel Pleural Air Leak Sealant without standard surgical closure (without suturing or stapling of visible air leaks incurred during resection of lung parenchyma).
Interventions
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). Standard closure means, for example, suturing or stapling of visible air leaks incurred during resection of lung parenchyma.
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). Standard closure means, for example, suturing or stapling of visible air leaks incurred during resection of lung parenchyma.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- C. R. Bardlead
Study Sites (18)
St. Vincent Birmingham & St. Vincent East
Birmingham, Alabama, 35243, United States
University of Alabama in Birmingham
Birmingham, Alabama, 35894, United States
Jacksonville Center for Research
Jacksonville, Florida, 32207, United States
Moffit Cancer Center
Tampa, Florida, 33612, United States
WellStar Research Institute
Atlanta, Georgia, 30060, United States
Emory University
Atlanta, Georgia, 30322, United States
Indiana University
Indianapolis, Indiana, 46202, United States
St. Vincent Hospital and Health Care Center
Indianapolis, Indiana, 46290, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Mass General Hospital
Boston, Massachusetts, 02114, United States
Brigham Womens' Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Deconess Medical Center
Boston, Massachusetts, 02215, United States
UMass Memorial Medical
Worcester, Massachusetts, 01605, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17602, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Dean Foundation for Health, Research and Education, Inc.
Madison, Wisconsin, 53715, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dawn Heimer, PhD
- Organization
- Davol, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Robert J. Cerfolio, MD
University of Alabama in Birmingham
- PRINCIPAL INVESTIGATOR
Daniel L. Miller, MD
WellStar Research Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2011
First Posted
July 15, 2011
Study Start
June 1, 2011
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
July 15, 2021
Results First Posted
July 11, 2017
Record last verified: 2021-07