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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P010047 / PAS001 |
| Date Original Protocol Accepted |
01/14/2010
|
| Date Current Protocol Accepted |
03/16/2015
|
| Study Name |
Long Term Safety
|
| Device Name |
PROGEL PLEURAL AIR LEAK SEALANT
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Prospective, non-randomized, controlled observational study with a ProGel PALS group and a comparison group of standard-of-care, multi-center cohort study.
|
| Study Population |
Newly enrolled consecutive patients post-approval study population
|
| Sample Size |
400 evaluable subjects (267 ProGEL Sealant + 133 Control) at up to 30 U.S. sites.
|
| Key Study Endpoints |
Primary Endpoints:
The study will include evaluation of twelve safety endpoints (i.e. specified AE). These include:
1. Pneumothorax
2. Air leak, persistent
3. Air leak, late onset
4. Residual pleural space
5. Acute respiratory distress syndrome (ARDS)
6. Post-surgical renal abnormalities
7. Myocardial infarction
8. Atrial arrhythmia requiring treatment
9. Ventricular arrhythmia requiring treatment
10. Cardiac arrest (resuscitated)
11. Death (all causes)
12. Hospital readmission (related to pulmonary surgery)
|
| Follow-up Visits and Length of Follow-up |
5 years: 30-day and 90-day follow-up visits are scheduled for study assessments
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
444 (400 subject as per protocol)
|
| Actual Number of Sites Enrolled |
22
|
| Patient Follow-up Rate |
The follow-up rate at the end of the study was 392 divided by 444= 88%
|
| Final Safety Findings |
Slightly lower rates were reported for persistent air leak in ProGel 14.5% vs. control 14.8%, [RR = 0.98 (95%CI: 0.62, 1.56) p = 0.937], and for atrial arrhythmia ProGel 16% vs. control 16% [RR = 0.99 (95%CI: 0.64, 1.55) p = 0.980]. Higher rate was reported for pneumothorax in ProGel 18.1% vs. control 10.5% [RR = 1.72 (95%CI: 1.03, 2.88) p = 0.033], and the association was statistically significant. ProGel group had 1.15 times more subjects with at least one specified adverse event. SAEs that occurred in greater than 3% in either group were hospital readmission 20 per 282 (7%) ProGel and 14 per 162 (9%) control, persistent air leak 23 per 282 (8%) ProGel and 15 per 162 (9%) control, pneumothorax ProGel 18 per 282 (6%) and control 8 per 162 (5%), atrial arrhythmia ProGel 2 per 282 (0.7%) and control 6 per 162 (4%), and death due to all causes 7 per 282 (3%) ProGel and 6 per 162 (4%) control. All other specified SAEs were reported in rates less than 1.5% in both groups. The rest of serious adverse event rates in the two study arms are pretty similar and lower or equal to the rate observed in the original PMA clinical report.
|
| Final Effect Findings |
No effectiveness study endpoints were included in the approved protocol.
|
| Study Strengths & Weaknesses |
Prospective cohort study design
Multi-center decreases potential selection bias and increases generalizability. The demographic distribution of patients reflects the population that requires this type of treatment.
Control group included
The follow-up rate of 88% is above the 80% that FDA recommends.
Study Weaknesses:
Non-randomized
44% of PAS treatment arm applications were off-label
|
| Recommendations for Labeling Changes |
Labeling changes are recommended based on safety data reported in the final report.
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