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NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study

Primary Purpose

Lung Cancer, Lung Tumor

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control
ProGEL Pleural Air Leak Sealant with standard surgical closure
ProGEL Pleural Air Leak Sealant without standard surgical closure
Sponsored by
C. R. Bard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Pleural air leak, Pulmonary resection, Open thoracotomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Vincent Birmingham & St. Vincent East
  • University of Alabama in Birmingham
  • Jacksonville Center for Research
  • Moffit Cancer Center
  • WellStar Research Institute
  • Emory University
  • Indiana University
  • St. Vincent Hospital and Health Care Center
  • Greater Baltimore Medical Center
  • Mass General Hospital
  • Brigham Womens' Hospital
  • Beth Israel Deconess Medical Center
  • UMass Memorial Medical
  • Mayo Clinic
  • Lancaster General Hospital
  • Virginia Commonwealth University Medical Center
  • Swedish Cancer Institute
  • Dean Foundation for Health, Research and Education, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Experimental

Arm Label

Control

ProGEL Pleural Air Leak Sealant with standard surgical closure

ProGEL Pleural Air Leak Sealant without standard surgical closure

Arm Description

No treatment.

Standard 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 (without suturing or stapling of visible air leaks incurred during resection of lung parenchyma).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 13, 2011
Last Updated
July 13, 2021
Sponsor
C. R. Bard
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1. Study Identification

Unique Protocol Identification Number
NCT01394978
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
C. R. Bard

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Lung Tumor
Keywords
Pleural air leak, Pulmonary resection, Open thoracotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
444 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
No treatment.
Arm Title
ProGEL Pleural Air Leak Sealant with standard surgical closure
Arm Type
Experimental
Arm Description
Standard surgical closure (suturing or stapling of visible air leaks incurred during resection of lung parenchyma) plus Progel Pleural Air Leak Sealant.
Arm Title
ProGEL Pleural Air Leak Sealant without standard surgical closure
Arm Type
Experimental
Arm Description
Progel Pleural Air Leak Sealant without standard surgical closure (without suturing or stapling of visible air leaks incurred during resection of lung parenchyma).
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Standard surgical techniques including staples and sutures.
Intervention Type
Device
Intervention Name(s)
ProGEL Pleural Air Leak Sealant with standard surgical closure
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
ProGEL Pleural Air Leak Sealant without standard surgical closure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety Endpoints
Description
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
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J. Cerfolio, MD
Organizational Affiliation
University of Alabama in Birmingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel L. Miller, MD
Organizational Affiliation
WellStar Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Vincent Birmingham & St. Vincent East
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Facility Name
University of Alabama in Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35894
Country
United States
Facility Name
Jacksonville Center for Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Moffit Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
WellStar Research Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
St. Vincent Hospital and Health Care Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Greater Baltimore Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Mass General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham Womens' Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
UMass Memorial Medical
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States
Facility Name
Virginia Commonwealth University Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Dean Foundation for Health, Research and Education, Inc.
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States

12. IPD Sharing Statement

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NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study

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