Trial Outcomes & Findings for NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study (NCT NCT01394978)
NCT ID: NCT01394978
Last Updated: 2021-07-15
Results Overview
* 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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
444 participants
Primary outcome timeframe
90 days
Results posted on
2021-07-15
Participant Flow
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.
Participant milestones
| Measure |
Control
No treatment.
Control: Standard surgical techniques including staples and sutures.
|
ProGEL Pleural Air Leak Sealant
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).
|
|---|---|---|
|
Overall Study
STARTED
|
168
|
276
|
|
Overall Study
COMPLETED
|
147
|
245
|
|
Overall Study
NOT COMPLETED
|
21
|
31
|
Reasons for withdrawal
| Measure |
Control
No treatment.
Control: Standard surgical techniques including staples and sutures.
|
ProGEL Pleural Air Leak Sealant
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).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
13
|
20
|
|
Overall Study
Death
|
6
|
7
|
Baseline Characteristics
NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study
Baseline characteristics by cohort
| Measure |
Control
n=168 Participants
No treatment.
Control: Standard surgical techniques including staples and sutures.
|
ProGEL Pleural Air Leak Sealant With Standard Surgical Closure
n=169 Participants
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 Without Standard Surgical Closure
n=107 Participants
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
n=444 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
69 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
191 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
99 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
253 Participants
n=4 Participants
|
|
Age, Continuous
|
65.7 years
STANDARD_DEVIATION 11.46 • n=5 Participants
|
64.8 years
STANDARD_DEVIATION 11.30 • n=7 Participants
|
66.7 years
STANDARD_DEVIATION 9.10 • n=5 Participants
|
65.6 years
STANDARD_DEVIATION 10.87 • n=4 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
217 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
227 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
156 Participants
n=5 Participants
|
161 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
414 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
168 participants
n=5 Participants
|
169 participants
n=7 Participants
|
107 participants
n=5 Participants
|
444 participants
n=4 Participants
|
|
Height
|
169.3 centimeters
STANDARD_DEVIATION 9.93 • n=5 Participants
|
171.0 centimeters
STANDARD_DEVIATION 9.72 • n=7 Participants
|
168.6 centimeters
STANDARD_DEVIATION 9.40 • n=5 Participants
|
169.8 centimeters
STANDARD_DEVIATION 9.74 • n=4 Participants
|
|
Weight
|
79.9 kilograms
STANDARD_DEVIATION 19.75 • n=5 Participants
|
82.0 kilograms
STANDARD_DEVIATION 21.43 • n=7 Participants
|
78.0 kilograms
STANDARD_DEVIATION 18.48 • n=5 Participants
|
80.3 kilograms
STANDARD_DEVIATION 20.22 • n=4 Participants
|
|
Body Mass Index (BMI)
|
27.8 kg/m^2
STANDARD_DEVIATION 6.16 • n=5 Participants
|
27.9 kg/m^2
STANDARD_DEVIATION 6.52 • n=7 Participants
|
27.3 kg/m^2
STANDARD_DEVIATION 5.47 • n=5 Participants
|
27.7 kg/m^2
STANDARD_DEVIATION 6.11 • n=4 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: 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.
* 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
Outcome measures
| Measure |
Control
n=111 Events
No treatment.
Control: Standard surgical techniques including staples and sutures.
|
ProGEL Pleural Air Leak Sealant
n=191 Events
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).
|
|---|---|---|
|
Safety Endpoints
Pneumothorax
|
22 Events
|
48 Events
|
|
Safety Endpoints
Persistent air leak
|
25 Events
|
40 Events
|
|
Safety Endpoints
Late onset air leak
|
1 Events
|
6 Events
|
|
Safety Endpoints
Residual pleural space
|
1 Events
|
1 Events
|
|
Safety Endpoints
Acute respiratory distress syndrome
|
1 Events
|
3 Events
|
|
Safety Endpoints
Renal abnormalities
|
5 Events
|
7 Events
|
|
Safety Endpoints
Myocardial Infarction
|
0 Events
|
2 Events
|
|
Safety Endpoints
Atrial Arrythmia
|
29 Events
|
48 Events
|
|
Safety Endpoints
Ventricular Arrythmia
|
5 Events
|
4 Events
|
|
Safety Endpoints
Cardiac Arrest, Resuscitated
|
0 Events
|
2 Events
|
|
Safety Endpoints
Death, all causes
|
6 Events
|
7 Events
|
|
Safety Endpoints
Hospital readmission
|
16 Events
|
23 Events
|
Adverse Events
Control
Serious events: 40 serious events
Other events: 39 other events
Deaths: 6 deaths
ProGEL Pleural Air Leak Sealant With Standard Surgical Closure
Serious events: 37 serious events
Other events: 52 other events
Deaths: 5 deaths
ProGEL Pleural Air Leak Sealant Without Standard Surgical Closure
Serious events: 27 serious events
Other events: 33 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Control
n=168 participants at risk
No treatment.
Control: Standard surgical techniques including staples and sutures.
|
ProGEL Pleural Air Leak Sealant With Standard Surgical Closure
n=169 participants at risk
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 Without Standard Surgical Closure
n=107 participants at risk
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).
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
4.8%
8/168 • 90 days post-index procedure
|
5.9%
10/169 • 90 days post-index procedure
|
7.5%
8/107 • 90 days post-index procedure
|
|
Respiratory, thoracic and mediastinal disorders
Persistent air leak
|
8.9%
15/168 • 90 days post-index procedure
|
10.7%
18/169 • 90 days post-index procedure
|
4.7%
5/107 • 90 days post-index procedure
|
|
Respiratory, thoracic and mediastinal disorders
Late onset air leak
|
0.00%
0/168 • 90 days post-index procedure
|
0.00%
0/169 • 90 days post-index procedure
|
3.7%
4/107 • 90 days post-index procedure
|
|
Respiratory, thoracic and mediastinal disorders
Residual Plueral Space
|
0.00%
0/168 • 90 days post-index procedure
|
0.00%
0/169 • 90 days post-index procedure
|
0.93%
1/107 • 90 days post-index procedure
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.60%
1/168 • 90 days post-index procedure
|
1.2%
2/169 • 90 days post-index procedure
|
0.93%
1/107 • 90 days post-index procedure
|
|
Renal and urinary disorders
Renal abnormalities
|
1.2%
2/168 • 90 days post-index procedure
|
1.8%
3/169 • 90 days post-index procedure
|
0.93%
1/107 • 90 days post-index procedure
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/168 • 90 days post-index procedure
|
0.59%
1/169 • 90 days post-index procedure
|
0.93%
1/107 • 90 days post-index procedure
|
|
Cardiac disorders
Atrial Arrhythmia
|
3.6%
6/168 • 90 days post-index procedure
|
0.59%
1/169 • 90 days post-index procedure
|
0.93%
1/107 • 90 days post-index procedure
|
|
Cardiac disorders
Ventricular Arrythmia
|
0.60%
1/168 • 90 days post-index procedure
|
0.00%
0/169 • 90 days post-index procedure
|
0.00%
0/107 • 90 days post-index procedure
|
|
Cardiac disorders
Cardiac arrest, resuscitated
|
0.00%
0/168 • 90 days post-index procedure
|
0.59%
1/169 • 90 days post-index procedure
|
0.93%
1/107 • 90 days post-index procedure
|
|
General disorders
Death, All Causes
|
3.6%
6/168 • 90 days post-index procedure
|
3.0%
5/169 • 90 days post-index procedure
|
1.9%
2/107 • 90 days post-index procedure
|
|
General disorders
Hospital Readmission
|
8.3%
14/168 • 90 days post-index procedure
|
4.7%
8/169 • 90 days post-index procedure
|
11.2%
12/107 • 90 days post-index procedure
|
Other adverse events
| Measure |
Control
n=168 participants at risk
No treatment.
Control: Standard surgical techniques including staples and sutures.
|
ProGEL Pleural Air Leak Sealant With Standard Surgical Closure
n=169 participants at risk
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 Without Standard Surgical Closure
n=107 participants at risk
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).
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
6.5%
11/168 • Number of events 11 • 90 days post-index procedure
|
13.0%
22/169 • Number of events 22 • 90 days post-index procedure
|
10.3%
11/107 • Number of events 11 • 90 days post-index procedure
|
|
Respiratory, thoracic and mediastinal disorders
Persistent Air Leak
|
5.4%
9/168 • Number of events 9 • 90 days post-index procedure
|
6.5%
11/169 • Number of events 22 • 90 days post-index procedure
|
6.5%
7/107 • Number of events 11 • 90 days post-index procedure
|
|
Cardiac disorders
Atrial Arrhythmia
|
11.9%
20/168 • Number of events 20 • 90 days post-index procedure
|
15.4%
26/169 • Number of events 26 • 90 days post-index procedure
|
15.9%
17/107 • 90 days post-index procedure
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place