Lung Cancer, Lung Tumor
Conditions
Keywords
Pleural air leak, Pulmonary resection, Open thoracotomy
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.
Interventions
OTHERControl
Standard surgical techniques including staples and sutures.
DEVICEProGEL 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.
DEVICEProGEL 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.
Sponsors
C. R. Bard
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Control No treatment.
Control: Standard surgical techniques including staples and sutures. | 168 |
| ProGEL Pleural Air Leak Sealant With Standard Surgical Closure 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. | 169 |
| ProGEL Pleural Air Leak Sealant Without Standard Surgical Closure 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. | 107 |
| Total | 444 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 6 | 7 |
| Overall Study | Lost to Follow-up | 13 | 20 |
| Overall Study | Withdrawal by Subject | 2 | 4 |
Baseline characteristics
| Characteristic | Control | ProGEL Pleural Air Leak Sealant With Standard Surgical Closure | ProGEL Pleural Air Leak Sealant Without Standard Surgical Closure | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 99 Participants | 91 Participants | 63 Participants | 253 Participants |
| Age, Categorical Between 18 and 65 years | 69 Participants | 78 Participants | 44 Participants | 191 Participants |
| Age, Continuous | 65.7 years STANDARD_DEVIATION 11.46 | 64.8 years STANDARD_DEVIATION 11.3 | 66.7 years STANDARD_DEVIATION 9.1 | 65.6 years STANDARD_DEVIATION 10.87 |
| Body Mass Index (BMI) | 27.8 kg/m^2 STANDARD_DEVIATION 6.16 | 27.9 kg/m^2 STANDARD_DEVIATION 6.52 | 27.3 kg/m^2 STANDARD_DEVIATION 5.47 | 27.7 kg/m^2 STANDARD_DEVIATION 6.11 |
| Height | 169.3 centimeters STANDARD_DEVIATION 9.93 | 171.0 centimeters STANDARD_DEVIATION 9.72 | 168.6 centimeters STANDARD_DEVIATION 9.4 | 169.8 centimeters STANDARD_DEVIATION 9.74 |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black | 8 Participants | 8 Participants | 7 Participants | 23 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 156 Participants | 161 Participants | 97 Participants | 414 Participants |
| Region of Enrollment United States | 168 participants | 169 participants | 107 participants | 444 participants |
| Sex: Female, Male Female | 81 Participants | 81 Participants | 55 Participants | 217 Participants |
| Sex: Female, Male Male | 87 Participants | 88 Participants | 52 Participants | 227 Participants |
| Weight | 79.9 kilograms STANDARD_DEVIATION 19.75 | 82.0 kilograms STANDARD_DEVIATION 21.43 | 78.0 kilograms STANDARD_DEVIATION 18.48 | 80.3 kilograms STANDARD_DEVIATION 20.22 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 6 / 168 | 5 / 169 | 2 / 107 |
| other Total, other adverse events | 39 / 168 | 52 / 169 | 33 / 107 |
| serious Total, serious adverse events | 40 / 168 | 37 / 169 | 27 / 107 |
Outcome results
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
Time frame: 90 days
Population: 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 | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Control | Safety Endpoints | Pneumothorax | 22 Events |
| Control | Safety Endpoints | Persistent air leak | 25 Events |
| Control | Safety Endpoints | Late onset air leak | 1 Events |
| Control | Safety Endpoints | Residual pleural space | 1 Events |
| Control | Safety Endpoints | Acute respiratory distress syndrome | 1 Events |
| Control | Safety Endpoints | Renal abnormalities | 5 Events |
| Control | Safety Endpoints | Myocardial Infarction | 0 Events |
| Control | Safety Endpoints | Atrial Arrythmia | 29 Events |
| Control | Safety Endpoints | Ventricular Arrythmia | 5 Events |
| Control | Safety Endpoints | Cardiac Arrest, Resuscitated | 0 Events |
| Control | Safety Endpoints | Death, all causes | 6 Events |
| Control | Safety Endpoints | Hospital readmission | 16 Events |
| ProGEL Pleural Air Leak Sealant | Safety Endpoints | Death, all causes | 7 Events |
| ProGEL Pleural Air Leak Sealant | Safety Endpoints | Pneumothorax | 48 Events |
| ProGEL Pleural Air Leak Sealant | Safety Endpoints | Myocardial Infarction | 2 Events |
| ProGEL Pleural Air Leak Sealant | Safety Endpoints | Persistent air leak | 40 Events |
| ProGEL Pleural Air Leak Sealant | Safety Endpoints | Cardiac Arrest, Resuscitated | 2 Events |
| ProGEL Pleural Air Leak Sealant | Safety Endpoints | Late onset air leak | 6 Events |
| ProGEL Pleural Air Leak Sealant | Safety Endpoints | Atrial Arrythmia | 48 Events |
| ProGEL Pleural Air Leak Sealant | Safety Endpoints | Residual pleural space | 1 Events |
| ProGEL Pleural Air Leak Sealant | Safety Endpoints | Hospital readmission | 23 Events |
| ProGEL Pleural Air Leak Sealant | Safety Endpoints | Acute respiratory distress syndrome | 3 Events |
| ProGEL Pleural Air Leak Sealant | Safety Endpoints | Ventricular Arrythmia | 4 Events |
| ProGEL Pleural Air Leak Sealant | Safety Endpoints | Renal abnormalities | 7 Events |