NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01394978
• Other study ID #: NEO09-100
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: February 2016

Study information

• Verified date: July 2021
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 444
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Lung Tumor

Intervention

Other:
• Control
Standard surgical techniques including staples and sutures.

Device:
• ProGEL Pleural Air Leak Sealant with standard surgical closure
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 Pleural Air Leak Sealant without standard surgical closure
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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	WellStar Research Institute	Atlanta	Georgia
United States	Greater Baltimore Medical Center	Baltimore	Maryland
United States	St. Vincent Birmingham & St. Vincent East	Birmingham	Alabama
United States	University of Alabama in Birmingham	Birmingham	Alabama
United States	Beth Israel Deconess Medical Center	Boston	Massachusetts
United States	Brigham Womens' Hospital	Boston	Massachusetts
United States	Mass General Hospital	Boston	Massachusetts
United States	Indiana University	Indianapolis	Indiana
United States	St. Vincent Hospital and Health Care Center	Indianapolis	Indiana
United States	Jacksonville Center for Research	Jacksonville	Florida
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	Dean Foundation for Health, Research and Education, Inc.	Madison	Wisconsin
United States	Virginia Commonwealth University Medical Center	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	Swedish Cancer Institute	Seattle	Washington
United States	Moffit Cancer Center	Tampa	Florida
United States	UMass Memorial Medical	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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