NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study
Sponsor
C. R. Bard (Industry)
Overall Status
Completed
CT.gov ID
NCT01394978
Collaborator
(none)
444
18
3
56
24.7
0.4
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
444 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date
:
Jun 1, 2011
Actual Primary Completion Date
:
Feb 1, 2016
Actual Study Completion Date
:
Feb 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Control No treatment. |
Other: Control
Standard surgical techniques including staples and sutures.
|
| Experimental: ProGEL Pleural Air Leak Sealant with standard surgical closure Standard surgical closure (suturing or stapling of visible air leaks incurred during resection of lung parenchyma) plus Progel Pleural Air Leak Sealant. |
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.
|
| Experimental: ProGEL Pleural Air Leak Sealant without standard surgical closure Progel Pleural Air Leak Sealant without standard surgical closure (without suturing or stapling of visible air leaks incurred during resection of lung parenchyma). |
Device: 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.
|
Outcome Measures
Primary Outcome Measures
- Safety Endpoints [90 days]
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
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. Vincent Birmingham & St. Vincent East | Birmingham | Alabama | United States | 35243 |
| 2 | University of Alabama in Birmingham | Birmingham | Alabama | United States | 35894 |
| 3 | Jacksonville Center for Research | Jacksonville | Florida | United States | 32207 |
| 4 | Moffit Cancer Center | Tampa | Florida | United States | 33612 |
| 5 | WellStar Research Institute | Atlanta | Georgia | United States | 30060 |
| 6 | Emory University | Atlanta | Georgia | United States | 30322 |
| 7 | Indiana University | Indianapolis | Indiana | United States | 46202 |
| 8 | St. Vincent Hospital and Health Care Center | Indianapolis | Indiana | United States | 46290 |
| 9 | Greater Baltimore Medical Center | Baltimore | Maryland | United States | 21204 |
| 10 | Mass General Hospital | Boston | Massachusetts | United States | 02114 |
| 11 | Brigham Womens' Hospital | Boston | Massachusetts | United States | 02115 |
| 12 | Beth Israel Deconess Medical Center | Boston | Massachusetts | United States | 02215 |
| 13 | UMass Memorial Medical | Worcester | Massachusetts | United States | 01605 |
| 14 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 15 | Lancaster General Hospital | Lancaster | Pennsylvania | United States | 17602 |
| 16 | Virginia Commonwealth University Medical Center | Richmond | Virginia | United States | 23298 |
| 17 | Swedish Cancer Institute | Seattle | Washington | United States | 98104 |
| 18 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
C. R. Bard
ClinicalTrials.gov Identifier:
NCT01394978
Other Study ID Numbers:
- NEO09-100
First Posted:
Jul 15, 2011
Last Update Posted:
Jul 15, 2021
Last Verified:
Jul 1, 2021
Keywords provided by C. R. Bard
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | The original Protocol was designed to study ProGel (any usage) versus no ProGel. After the study was completed, the FDA requested that the ProGel group be broken out by patients with standard closure, and without. |
| Arm/Group Title | Control | ProGEL Pleural Air Leak Sealant |
|---|---|---|
| Arm/Group Description | No treatment. Control: Standard surgical techniques including staples and sutures. | Standard surgical technique plus Progel Pleural Air Leak Sealant. 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). |
| Period Title: Overall Study | ||
| STARTED | 168 | 276 |
| COMPLETED | 147 | 245 |
| NOT COMPLETED | 21 | 31 |
Baseline Characteristics
| Arm/Group Title | Control | ProGEL Pleural Air Leak Sealant With Standard Surgical Closure | ProGEL Pleural Air Leak Sealant Without Standard Surgical Closure | Total |
|---|---|---|---|---|
| Arm/Group Description | No treatment. Control: Standard surgical techniques including staples and sutures. | 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). Standard closure, for example, by suturing or stapling, of visible air leaks incurred during resection of lung parenchyma. | 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). Without standard closure, for example, suturing or stapling, of visible air leaks incurred during resection of lung parenchyma. | Total of all reporting groups |
| Overall Participants | 168 | 169 | 107 | 444 |
| Age (Count of Participants) | ||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
69
41.1%
|
78
46.2%
|
44
41.1%
|
191
43%
|
| >=65 years |
99
58.9%
|
91
53.8%
|
63
58.9%
|
253
57%
|
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
65.7
(11.46)
|
64.8
(11.30)
|
66.7
(9.10)
|
65.6
(10.87)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
81
48.2%
|
81
47.9%
|
55
51.4%
|
217
48.9%
|
| Male |
87
51.8%
|
88
52.1%
|
52
48.6%
|
227
51.1%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||
| White |
156
92.9%
|
161
95.3%
|
97
90.7%
|
414
93.2%
|
| Black |
8
4.8%
|
8
4.7%
|
7
6.5%
|
23
5.2%
|
| Asian |
1
0.6%
|
0
0%
|
1
0.9%
|
2
0.5%
|
| Hispanic |
2
1.2%
|
0
0%
|
1
0.9%
|
3
0.7%
|
| Other |
1
0.6%
|
0
0%
|
1
0.9%
|
2
0.5%
|
| Region of Enrollment (participants) [Number] | ||||
| United States |
168
100%
|
169
100%
|
107
100%
|
444
100%
|
| Height (centimeters) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [centimeters] |
169.3
(9.93)
|
171.0
(9.72)
|
168.6
(9.40)
|
169.8
(9.74)
|
| Weight (kilograms) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [kilograms] |
79.9
(19.75)
|
82.0
(21.43)
|
78.0
(18.48)
|
80.3
(20.22)
|
| Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [kg/m^2] |
27.8
(6.16)
|
27.9
(6.52)
|
27.3
(5.47)
|
27.7
(6.11)
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Units analyzed represents the number of adverse events that occurred among all study participants in each arm. Also, the original Protocol was designed to study ProGel (any usage) versus no ProGel. After the study was completed, the FDA requested that the ProGel group be broken out by patients with standard closure, and without. |
| Arm/Group Title | Control | ProGEL Pleural Air Leak Sealant |
|---|---|---|
| Arm/Group Description | No treatment. Control: Standard surgical techniques including staples and sutures. | Standard surgical technique plus Progel Pleural Air Leak Sealant. 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). |
| Measure Participants | 168 | 276 |
| Measure Events | 111 | 191 |
| Pneumothorax |
22
|
48
|
| Persistent air leak |
25
|
40
|
| Late onset air leak |
1
|
6
|
| Residual pleural space |
1
|
1
|
| Acute respiratory distress syndrome |
1
|
3
|
| Renal abnormalities |
5
|
7
|
| Myocardial Infarction |
0
|
2
|
| Atrial Arrythmia |
29
|
48
|
| Ventricular Arrythmia |
5
|
4
|
| Cardiac Arrest, Resuscitated |
0
|
2
|
| Death, all causes |
6
|
7
|
| Hospital readmission |
16
|
23
|
Adverse Events
| Time Frame | 90 days post-index procedure | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Control | ProGEL Pleural Air Leak Sealant With Standard Surgical Closure | ProGEL Pleural Air Leak Sealant Without Standard Surgical Closure | |||
| Arm/Group Description | No treatment. Control: Standard surgical techniques including staples and sutures. | 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). Standard surgical closure (standard closure with, sutures or staples, for example) plus Progel Pleural Air Leak Sealant. | 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). Progel Pleural Air Leak Sealant without standard surgical closure (standard closure with, sutures or staples, for example). | |||
All Cause Mortality |
||||||
| Control | ProGEL Pleural Air Leak Sealant With Standard Surgical Closure | ProGEL Pleural Air Leak Sealant Without Standard Surgical Closure | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/168 (3.6%) | 5/169 (3%) | 2/107 (1.9%) | |||
Serious Adverse Events |
||||||
| Control | ProGEL Pleural Air Leak Sealant With Standard Surgical Closure | ProGEL Pleural Air Leak Sealant Without Standard Surgical Closure | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 40/168 (23.8%) | 37/169 (21.9%) | 27/107 (25.2%) | |||
| Cardiac disorders | ||||||
| Myocardial Infarction | 0/168 (0%) | 1/169 (0.6%) | 1/107 (0.9%) | |||
| Atrial Arrhythmia | 6/168 (3.6%) | 1/169 (0.6%) | 1/107 (0.9%) | |||
| Ventricular Arrythmia | 1/168 (0.6%) | 0/169 (0%) | 0/107 (0%) | |||
| Cardiac arrest, resuscitated | 0/168 (0%) | 1/169 (0.6%) | 1/107 (0.9%) | |||
| General disorders | ||||||
| Death, All Causes | 6/168 (3.6%) | 5/169 (3%) | 2/107 (1.9%) | |||
| Hospital Readmission | 14/168 (8.3%) | 8/169 (4.7%) | 12/107 (11.2%) | |||
| Renal and urinary disorders | ||||||
| Renal abnormalities | 2/168 (1.2%) | 3/169 (1.8%) | 1/107 (0.9%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Pneumothorax | 8/168 (4.8%) | 10/169 (5.9%) | 8/107 (7.5%) | |||
| Persistent air leak | 15/168 (8.9%) | 18/169 (10.7%) | 5/107 (4.7%) | |||
| Late onset air leak | 0/168 (0%) | 0/169 (0%) | 4/107 (3.7%) | |||
| Residual Plueral Space | 0/168 (0%) | 0/169 (0%) | 1/107 (0.9%) | |||
| Acute respiratory distress syndrome | 1/168 (0.6%) | 2/169 (1.2%) | 1/107 (0.9%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Control | ProGEL Pleural Air Leak Sealant With Standard Surgical Closure | ProGEL Pleural Air Leak Sealant Without Standard Surgical Closure | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 39/168 (23.2%) | 52/169 (30.8%) | 33/107 (30.8%) | |||
| Cardiac disorders | ||||||
| Atrial Arrhythmia | 20/168 (11.9%) | 20 | 26/169 (15.4%) | 26 | 17/107 (15.9%) | 26 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Pneumothorax | 11/168 (6.5%) | 11 | 22/169 (13%) | 22 | 11/107 (10.3%) | 11 |
| Persistent Air Leak | 9/168 (5.4%) | 9 | 11/169 (6.5%) | 22 | 7/107 (6.5%) | 11 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dawn Heimer, PhD |
|---|---|
| Organization | Davol, Inc. |
| Phone | +1-401-825-8681 |
| Dawn.Heimer@CRBard.com |
Responsible Party:
C. R. Bard
ClinicalTrials.gov Identifier:
NCT01394978
Other Study ID Numbers:
- NEO09-100
First Posted:
Jul 15, 2011
Last Update Posted:
Jul 15, 2021
Last Verified:
Jul 1, 2021