Clinical trial NCT01394978: NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lung Tumor
Keywords: Pleural air leak
Pulmonary resection
Open thoracotomy
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2011-07-15
Enrollment: 444
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Safety Endpoints
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: St. Vincent Birmingham & St. Vincent East
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama in Birmingham
state: Alabama
city: Jacksonville
country: United States
facility: Jacksonville Center for Research
state: Florida
city: Tampa
country: United States
facility: Moffit Cancer Center
state: Florida
city: Atlanta
country: United States
facility: WellStar Research Institute
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Hospital and Health Care Center
state: Indiana
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Boston
country: United States
facility: Mass General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham Womens' Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deconess Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Madison
country: United States
facility: Dean Foundation for Health, Research and Education, Inc.
state: Wisconsin
Study officials:
affiliation: University of Alabama in Birmingham
name: Robert J. Cerfolio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: WellStar Research Institute
name: Daniel L. Miller, MD
role: PRINCIPAL_INVESTIGATOR
References: